{
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    "occurred": "au:occurred",
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  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2170-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282).",
  "description": "FDA recall Z-2170-2026 — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is recalling Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282). (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2170-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282).",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2170-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2170-2026: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is recalling Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282).",
      "text": "The FDA logged enforcement record Z-2170-2026: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is voluntarily recalling Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282). — reason: Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-03-31. Affected lots/codes: 1. System Code Description: Azurion 3 M12. Model Number [UDI]: 722221 [(01)00884838099203(21)181, (01)00884838099203(21)178, (01)00884838099203(21)93];  722229 [(01)00884838116726(21)22, (01)00884838116726(21)9, (01)00884838116726(21)16, (01)00884838116726(21)15, (01)00884838116726(21)5, (01)00884838116726(21)3, (01)00884838116726(21)4, (01)00884838116726(21)6, (01)00884838116726(21)2, (01)00884838116726(21)8].   2. System Code Description: Azurion 3 M15. Model Number [UDI]: 722222 [(01)00884838099210(21)358, (01)00884838099210(21)328, (01)00884838099210(21)389, (01)00884838099210(21)378, (01)00884838099210(21)243, (01)00884838099210(21)392, (01)00884838099210(21)396, (01)00884838099210(21)13, (01)00884838099210(21)379, (01)00884838099210(21)385, (01)00884838099210(21)376, (01)00884838099210(21)366, (01)00884838099210(21)365, (01)00884838099210(21)398, (01)00884838099210(21)274]; 722230 [(01)00884838116733(21)40, (01)00884838116733(21)2, (01)00884838116733(21)41, (01)00884838116733(21)15, (01)00884838116733(21)28, (01)00884838116733(21)38, (01)00884838116733(21)9, (01)00884838116733(21)27, (01)00884838116733(21)13].  3. System Code Description: Azurion 5. Model Number [UDI]: 722281 [(01)00884838110564(21)401, (01)00884838110564(21)427, (01)00884838110564(21)382, (01)00884838110564(21)425].  4. System Code Description: Azurion 5 M12. Model Number [UDI]:  722227 [(01)00884838099227(21)265, (01)00884838099227(21)360, (01)00884838099227(21)320, (01)00884838099227(21)338, (01)00884838099227(21)324, (01)00884838099227(21)305, (01)00884838099227(21)356, (01)00884838099227(21)346, (01)00884838099227(21)313, (01)00884838099227(21)339, (01)00884838099227(21)321, (01)00884838099227(21)247, (01)00884838099227(21)298, (01)00884838099227(21)337, (01)00884838099227(21)306, (01)00884838099227(21)336, (01)00884838099227(21)318, (01)00884838099227(21)353, (01)00884838099227(21)309, (01)00884838099227(21)310, (01)00884838099227(21)316, (01)00884838099227(21)272, (01)00884838099227(21)345, (01)00884838099227(21)351, (01)00884838099227(21)352, (01)00884838099227(21)258, (01)00884838099227(21)326, (01)00884838099227(21)348, (01)00884838099227(21)355, (01)00884838099227(21)315, (01)00884838099227(21)280, (01)00884838099227(21)300, (01)00884838099227(21)335, (01)00884838099227(21)344, (01)00884838099227(21)308, (01)00884838099227(21)362, (01)00884838099227(21)323, (01)00884838099227(21)331, (01)00884838099227(21)269, (01)00884838099227(21)294, (01)00884838099227(21)342, (01)00884838099227(21)330, (01)00884838099227(21)340, (01)00884838099227(21)284, (01)00884838099227(21)333, (01)00884838099227(21)253, (01)00884838099227(21)301, (01)00884838099227(21)332, (01)00884838099227(21)334, (01)00884838099227(21)297, (01)00884838099227(21)350, (01)00884838099227(21)307, (01)00884838099227(21)311, (01)00884838099227(21)319, (01)00884838099227(21)286, (01)00884838099227(21)329, (01)00884838099227(21)208, (01)00884838099227(21)178]; 722231 [(01)00884838116740(21)52, (01)00884838116740(21)49, (01)00884838116740(21)50, (01)00884838116740(21)41, (01)00884838116740(21)21, (01)00884838116740(21)53, (01)00884838116740(21)47, (01)00884838116740(21)3, (01)00884838116740(21)25, (01)00884838116740(21)34, (01)00884838116740(21)61, (01)00884838116740(21)26, (01)00884838116740(21)7, (01)00884838116740(21)8, (01)00884838116740(21)4, (01)00884838116740(21)5, (01)00884838116740(21)12, (01)00884838116740(21)60, (01)00884838116740(21)28, (01)00884838116740(21)45, (01)00884838116740(21)20, (01)00884838116740(21)19, (01)00884838116740(21)51, (01)00884838116740(21)29, (01)00884838116740(21)27, (01)00884838116740(21)11, (01)00884838116740(21)35, (01)00884838116740(21)62, (01)00884838116740(21)54, (01)00884838116740(21)33, (01)00884838116740(21)1, (01)00884838116740(21)2, (01)00884838116740(21)32].    5. System Code Description: Azurion 5 M20. Model Number [UDI]:  722228 [(01)00884838099234(21)481, (01)00884838099234(21)537, (01)00884838099234(21)615, (01)00884838099234(21)538, (01)00884838099234(21)533, (01)00884838099234(21)522, (01)00884838099234(21)600, (01)00884838099234(21)642, (01)00884838099234(21)573, (01)00884838099234(21)659, (01)00884838099234(21)567, (01)00884838099234(21)645, (01)00884838099234(21)570, (01)00884838099234(21)560, (01)00884838099234(21)569, (01)00884838099234(21)616, (01)00884838099234(21)568, (01)00884838099234(21)629, (01)00884838099234(21)566, (01)00884838099234(21)571, (01)00884838099234(21)647, (01)00884838099234(21)562, (01)00884838099234(21)640, (01)00884838099234(21)676, (01)00884838099234(21)677, (01)00884838099234(21)602, (01)00884838099234(21)461, (01)00884838099234(21)613, (01)00884838099234(21)393, (01)00884838099234(21)660, (01)00884838099234(21)673, (01)00884838099234(21)580, (01)00884838099234(21)668, (01)00884838099234(21)623, (01)00884838099234(21)486, (01)00884838099234(21)487, 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(01)00884838110564(21)188, (01)00884838110564(21)340, (01)00884838110564(21)68, (01)00884838110564(21)151, (01)00884838110564(21)141, (01)00884838110564(21)221, (01)00884838110564(21)41, (01)00884838110564(21)289, (01)00884838110564(21)246, (01)00884838110564(21)83, (01)00884838110564(21)284, (01)00884838110564(21)177, (01)00884838110564(21)39, (01)00884838110564(21)40, (01)00884838110564(21)43, (01)00884838110564(21)331, (01)00884838110564(21)212, (01)00884838110564(21)122, (01)00884838110564(21)178, (01)00884838110564(21)191, (01)00884838110564(21)194, (01)00884838110564(21)200, (01)00884838110564(21)250, (01)00884838110564(21)251, (01)00884838110564(21)132, (01)00884838110564(21)325, (01)00884838110564(21)205, (01)00884838110564(21)82, (01)00884838110564(21)332, (01)00884838110564(21)222, (01)00884838110564(21)138, (01)00884838110564(21)174, (01)00884838110564(21)311, (01)00884838110564(21)312, (01)00884838110564(21)121, (01)00884838110564(21)300, (01)00884838110564(21)90, (01)00884838110564(21)96, (01)00884838110564(21)231, (01)00884838110564(21)123, (01)00884838110564(21)424, (01)00884838110564(21)298, (01)00884838110564(21)264, (01)00884838110564(21)160, (01)00884838110564(21)91, (01)00884838110564(21)292, (01)00884838110564(21)18, (01)00884838110564(21)87, (01)00884838110564(21)49, (01)00884838110564(21)166, (01)00884838110564(21)72, (01)00884838110564(21)274, (01)00884838110564(21)47, (01)00884838110564(21)242, (01)00884838110564(21)324, (01)00884838110564(21)144, (01)00884838110564(21)158, (01)00884838110564(21)234, (01)00884838110564(21)224, (01)00884838110564(21)198, (01)00884838110564(21)206, (01)00884838110564(21)118, (01)00884838110564(21)58, (01)00884838110564(21)133, (01)00884838110564(21)193, (01)00884838110564(21)280, (01)00884838110564(21)137, (01)00884838110564(21)103, (01)00884838110564(21)196, (01)00884838110564(21)139, (01)00884838110564(21)173, (01)00884838110564(21)143, (01)00884838110564(21)239, (01)00884838110564(21)15, (01)00884838110564(21)163, (01)00884838110564(21)111, (01)00884838110564(21)252, (01)00884838110564(21)230, (01)00884838110564(21)42, (01)00884838110564(21)213, (01)00884838110564(21)220, (01)00884838110564(21)25, (01)00884838110564(21)106, (01)00884838110564(21)142, (01)00884838110564(21)84, (01)00884838110564(21)16, (01)00884838110564(21)431, (01)00884838110564(21)257, (01)00884838110564(21)241, (01)00884838110564(21)243, (01)00884838110564(21)165, (01)00884838110564(21)147, (01)00884838110564(21)248, (01)00884838110564(21)288].   6. System Code Description: Azurion 7. Model Number [UDI]: 722282 [(01)00884838110571(21)144, (01)00884838110571(21)92, (01)00884838110571(21)123].   7. System Code Description: Azurion 7 B12. Model Number [UDI]: 722225 [(01)00884838099265(21)400, (01)00884838099265(21)453, (01)00884838099265(21)434, (01)00884838099265(21)435, (01)00884838099265(21)409, (01)00884838099265(21)455, (01)00884838099265(21)468, (01)00884838099265(21)462, (01)00884838099265(21)431, (01)00884838099265(21)450, (01)00884838099265(21)460, (01)00884838099265(21)469, (01)00884838099265(21)470, (01)00884838099265(21)437, (01)00884838099265(21)465, (01)00884838099265(21)457, (01)00884838099265(21)461, (01)00884838099265(21)426, (01)00884838099265(21)454, (01)00884838099265(21)418, (01)00884838099265(21)438, (01)00884838099265(21)366, (01)00884838099265(21)451, (01)00884838099265(21)452, (01)00884838099265(21)254, (01)00884838099265(21)392, (01)00884838099265(21)456, (01)00884838099265(21)442, (01)00884838099265(21)447, (01)00884838099265(21)446, (01)00884838099265(21)448, (01)00884838099265(21)459, (01)00884838099265(21)439, (01)00884838099265(21)471, (01)00884838099265(21)472, (01)00884838099265(21)251, (01)00884838099265(21)253, (01)00884838099265(21)441, (01)00884838099265(21)411, (01)00884838099265(21)252, (01)00884838099265(21)1, (01)00884838099265(21)396, (01)00884838099265(21)178, (01)00884838099265(21)445]; 722235 [(01)00884838116788(21)77, (01)00884838116788(21)76, (01)00884838116788(21)102, (01)00884838116788(21)59, (01)00884838116788(21)71, (01)00884838116788(21)11, (01)00884838116788(21)13, (01)00884838116788(21)41, (01)00884838116788(21)94, (01)00884838116788(21)70, (01)00884838116788(21)54, (01)00884838116788(21)47, (01)00884838116788(21)79, (01)00884838116788(21)93, (01)00884838116788(21)72, (01)00884838116788(21)27, (01)00884838116788(21)14, (01)00884838116788(21)20, (01)00884838116788(21)56, (01)00884838116788(21)30, (01)00884838116788(21)31, (01)00884838116788(21)10, (01)00884838116788(21)3, (01)00884838116788(21)99, (01)00884838116788(21)82, (01)00884838116788(21)83, (01)00884838116788(21)84, (01)00884838116788(21)100, (01)00884838116788(21)66, (01)00884838116788(21)67, (01)00884838116788(21)96, (01)00884838116788(21)63, (01)00884838116788(21)34, (01)00884838116788(21)28, (01)00884838116788(21)17, (01)00884838116788(21)18, (01)00884838116788(21)65, (01)00884838116788(21)40, (01)00884838116788(21)45, (01)00884838116788(21)44, (01)00884838116788(21)42, (01)00884838116788(21)52, (01)00884838116788(21)49, (01)00884838116788(21)101, (01)00884838116788(21)53, (01)00884838116788(21)81, (01)00884838116788(21)25, (01)00884838116788(21)24, (01)00884838116788(21)6, (01)00884838116788(21)38, (01)00884838116788(21)39, (01)00884838116788(21)7, (01)00884838116788(21)5, (01)00884838116788(21)8, (01)00884838116788(21)58, (01)00884838116788(21)111, (01)00884838116788(21)98, (01)00884838116788(21)64, (01)00884838116788(21)9, (01)00884838116788(21)35, (01)00884838116788(21)19, (01)00884838116788(21)23, (01)00884838116788(21)21, (01)00884838116788(21)33].   8. System Code Description: Azurion 7 B20. Model Number [UDI]: 722068 [(01)00884838085367(21)113]; 722226 [(01)00884838099272(21)1052, (01)00884838099272(21)1091, (01)00884838099272(21)1078, (01)00884838099272(21)1145, (01)00884838099272(21)891, (01)00884838099272(21)1021, (01)00884838099272(21)955, (01)00884838099272(21)683, (01)00884838099272(21)1017, (01)00884838099272(21)894, (01)00884838099272(21)973, (01)00884838099272(21)1125, (01)00884838099272(21)987, (01)00884838099272(21)1050, (01)00884838099272(21)1139, (01)00884838099272(21)1062, (01)00884838099272(21)1121, (01)00884838099272(21)1046, (01)00884838099272(21)1083, (01)00884838099272(21)1126, (01)00884838099272(21)977, (01)00884838099272(21)1113, (01)00884838099272(21)1043, (01)00884838099272(21)797, (01)00884838099272(21)1097, (01)00884838099272(21)1094, (01)00884838099272(21)1107, (01)00884838099272(21)1092, (01)00884838099272(21)1143, (01)00884838099272(21)1073, (01)00884838099272(21)1027, (01)00884838099272(21)1067, (01)00884838099272(21)1114, (01)00884838099272(21)1102, (01)00884838099272(21)1060, (01)00884838099272(21)972, (01)00884838099272(21)1136, (01)00884838099272(21)944, (01)00884838099272(21)1123, (01)00884838099272(21)1039, (01)00884838099272(21)1049, (01)00884838099272(21)909, (01)00884838099272(21)754, (01)00884838099272(21)1057, (01)00884838099272(21)911, (01)00884838099272(21)1103, (01)00884838099272(21)1069, (01)00884838099272(21)1076, (01)00884838099272(21)1054, (01)00884838099272(21)1048, (01)00884838099272(21)1132, (01)00884838099272(21)548, (01)00884838099272(21)895, (01)00884838099272(21)1087, (01)00884838099272(21)956, (01)00884838099272(21)1077, (01)00884838099272(21)1072, (01)00884838099272(21)1026, (01)00884838099272(21)1129, (01)00884838099272(21)1144, (01)00884838099272(21)1041, (01)00884838099272(21)1053, (01)00884838099272(21)1071, (01)00884838099272(21)1099, (01)00884838099272(21)552, (01)00884838099272(21)1047, (01)00884838099272(21)1127, (01)00884838099272(21)1115, (01)00884838099272(21)699, (01)00884838099272(21)1064, (01)00884838099272(21)1137, (01)00884838099272(21)1111, (01)00884838099272(21)1075, (01)00884838099272(21)1023, (01)00884838099272(21)1135, (01)00884838099272(21)1036, (01)00884838099272(21)1104, (01)00884838099272(21)938, (01)00884838099272(21)1066, (01)00884838099272(21)939, (01)00884838099272(21)1065, (01)00884838099272(21)1038, (01)00884838099272(21)1133, (01)00884838099272(21)1124, (01)00884838099272(21)1022, (01)00884838099272(21)1020, (01)00884838099272(21)1059, (01)00884838099272(21)1118, (01)00884838099272(21)1080, (01)00884838099272(21)1089, (01)00884838099272(21)1035, (01)00884838099272(21)1055, (01)00884838099272(21)532, (01)00884838099272(21)1093, (01)00884838099272(21)1079, (01)00884838099272(21)1106, (01)00884838099272(21)546, (01)00884838099272(21)1058, (01)00884838099272(21)1032, (01)00884838099272(21)3, (01)00884838099272(21)1034]; 722236 [(01)00884838116801(21)37, (01)00884838116801(21)24, (01)00884838116801(21)212, (01)00884838116801(21)25, (01)00884838116801(21)227, (01)00884838116801(21)235, (01)00884838116801(21)226, (01)00884838116801(21)26, (01)00884838116801(21)20, (01)00884838116801(21)249, (01)00884838116801(21)208, (01)00884838116801(21)42, (01)00884838116801(21)205, (01)00884838116801(21)36, (01)00884838116801(21)183, (01)00884838116801(21)133, (01)00884838116801(21)31, (01)00884838116801(21)194, (01)00884838116801(21)158, (01)00884838116801(21)99, (01)00884838116801(21)21, (01)00884838116801(21)40, (01)00884838116801(21)118, (01)00884838116801(21)39, (01)00884838116801(21)233, (01)00884838116801(21)48, (01)00884838116801(21)197, (01)00884838116801(21)221, (01)00884838116801(21)68, (01)00884838116801(21)230, (01)00884838116801(21)38, (01)00884838116801(21)22, (01)00884838116801(21)186, (01)00884838116801(21)134, (01)00884838116801(21)330, (01)00884838116801(21)357, (01)00884838116801(21)289, (01)00884838116801(21)67, (01)00884838116801(21)242, (01)00884838116801(21)223, (01)00884838116801(21)13, (01)00884838116801(21)215, (01)00884838116801(21)348, (01)00884838116801(21)244, (01)00884838116801(21)117, (01)00884838116801(21)201, (01)00884838116801(21)278, (01)00884838116801(21)271, (01)00884838116801(21)34, (01)00884838116801(21)122, (01)00884838116801(21)162, (01)00884838116801(21)93, (01)00884838116801(21)207, (01)00884838116801(21)232, (01)00884838116801(21)216, (01)00884838116801(21)219, (01)00884838116801(21)56, (01)00884838116801(21)57, (01)00884838116801(21)91, (01)00884838116801(21)44, (01)00884838116801(21)234, (01)00884838116801(21)156, (01)00884838116801(21)274, (01)00884838116801(21)237, (01)00884838116801(21)113, (01)00884838116801(21)46, (01)00884838116801(21)292, (01)00884838116801(21)66, (01)00884838116801(21)165, (01)00884838116801(21)163, (01)00884838116801(21)283, (01)00884838116801(21)284, (01)00884838116801(21)285, (01)00884838116801(21)193, (01)00884838116801(21)297, (01)00884838116801(21)269, (01)00884838116801(21)102, (01)00884838116801(21)132, (01)00884838116801(21)157, (01)00884838116801(21)98, (01)00884838116801(21)189, (01)00884838116801(21)30, (01)00884838116801(21)146, (01)00884838116801(21)125, (01)00884838116801(21)182, (01)00884838116801(21)329, (01)00884838116801(21)100, (01)00884838116801(21)123, (01)00884838116801(21)23, (01)00884838116801(21)96, (01)00884838116801(21)181, (01)00884838116801(21)188, (01)00884838116801(21)258, (01)00884838116801(21)130, (01)00884838116801(21)114, (01)00884838116801(21)154, (01)00884838116801(21)264, (01)00884838116801(21)126, (01)00884838116801(21)128, (01)00884838116801(21)86, (01)00884838116801(21)94, (01)00884838116801(21)160, (01)00884838116801(21)170, (01)00884838116801(21)82, (01)00884838116801(21)63, (01)00884838116801(21)268, (01)00884838116801(21)277, (01)00884838116801(21)111, (01)00884838116801(21)172, (01)00884838116801(21)112, (01)00884838116801(21)259, (01)00884838116801(21)103, (01)00884838116801(21)75, (01)00884838116801(21)84, (01)00884838116801(21)52, (01)00884838116801(21)73, (01)00884838116801(21)80, (01)00884838116801(21)175, (01)00884838116801(21)305, (01)00884838116801(21)92, (01)00884838116801(21)155, (01)00884838116801(21)55, (01)00884838116801(21)85, (01)00884838116801(21)142, (01)00884838116801(21)105, (01)00884838116801(21)108, (01)00884838116801(21)53, (01)00884838116801(21)144, (01)00884838116801(21)198, (01)00884838116801(21)141, (01)00884838116801(21)299, (01)00884838116801(21)124, (01)00884838116801(21)62, (01)00884838116801(21)261, (01)00884838116801(21)88, (01)00884838116801(21)89, (01)00884838116801(21)83, (01)00884838116801(21)171, (01)00884838116801(21)240, (01)00884838116801(21)76, (01)00884838116801(21)106, (01)00884838116801(21)90, (01)00884838116801(21)251, (01)00884838116801(21)49, (01)00884838116801(21)74, (01)00884838116801(21)78, (01)00884838116801(21)59, (01)00884838116801(21)104, (01)00884838116801(21)70, (01)00884838116801(21)107, (01)00884838116801(21)64, (01)00884838116801(21)151, (01)00884838116801(21)152, (01)00884838116801(21)69, (01)00884838116801(21)153].   9. System Code Description: Azurion 7 M12. Model Number [UDI]: 722078 [(01)00884838085251(21)1082]; 722223 [(01)00884838099241(21)1038, (01)00884838099241(21)1052, (01)00884838099241(21)1130, (01)00884838099241(21)855, (01)00884838099241(21)1051, (01)00884838099241(21)1241, (01)00884838099241(21)1107, (01)00884838099241(21)1015, (01)00884838099241(21)1231, (01)00884838099241(21)1067, (01)00884838099241(21)1113, (01)00884838099241(21)850, (01)00884838099241(21)1242, (01)00884838099241(21)1211, (01)00884838099241(21)1132, (01)00884838099241(21)1061, (01)00884838099241(21)1296, (01)00884838099241(21)835, (01)00884838099241(21)1185, (01)00884838099241(21)1188, (01)00884838099241(21)1236, (01)00884838099241(21)714, (01)00884838099241(21)1227, (01)00884838099241(21)1264, (01)00884838099241(21)1226, (01)00884838099241(21)1210, (01)00884838099241(21)1290, (01)00884838099241(21)1293, (01)00884838099241(21)1131, (01)00884838099241(21)1282, (01)00884838099241(21)1325, (01)00884838099241(21)1245, (01)00884838099241(21)1214, (01)00884838099241(21)1232, (01)00884838099241(21)1248, (01)00884838099241(21)1256, (01)00884838099241(21)963, (01)00884838099241(21)1222, (01)00884838099241(21)1217, (01)00884838099241(21)1272, (01)00884838099241(21)1283, (01)00884838099241(21)1196, (01)00884838099241(21)1258, (01)00884838099241(21)1212, (01)00884838099241(21)1243, (01)00884838099241(21)1295, (01)00884838099241(21)1125, (01)00884838099241(21)1284, (01)00884838099241(21)1251, (01)00884838099241(21)1271, (01)00884838099241(21)978, (01)00884838099241(21)1276, (01)00884838099241(21)1262, (01)00884838099241(21)1263, (01)00884838099241(21)1247, (01)00884838099241(21)1147, (01)00884838099241(21)1237, (01)00884838099241(21)1301, (01)00884838099241(21)1011, (01)00884838099241(21)1267, (01)00884838099241(21)1246, (01)00884838099241(21)1259, (01)00884838099241(21)1261, (01)00884838099241(21)1291, (01)00884838099241(21)1289, (01)00884838099241(21)1285, (01)00884838099241(21)418, (01)00884838099241(21)759, (01)00884838099241(21)1280, (01)00884838099241(21)1275, (01)00884838099241(21)1268, (01)00884838099241(21)1092, (01)00884838099241(21)6, (01)00884838099241(21)1286, (01)00884838099241(21)1117, (01)00884838099241(21)1239, (01)00884838099241(21)985, (01)00884838099241(21)1186, (01)00884838099241(21)481, (01)00884838099241(21)828, (01)00884838099241(21)1250, (01)00884838099241(21)1270, (01)00884838099241(21)766, (01)00884838099241(21)1172, (01)00884838099241(21)1310, (01)00884838099241(21)1253, (01)00884838099241(21)1254, (01)00884838099241(21)1304, (01)00884838099241(21)1287, (01)00884838099241(21)1288, (01)00884838099241(21)1198, (01)00884838099241(21)1317, (01)00884838099241(21)1302, (01)00884838099241(21)1128, (01)00884838099241(21)1321, (01)00884838099241(21)1322, (01)00884838099241(21)935, (01)00884838099241(21)1218, (01)00884838099241(21)1225, (01)00884838099241(21)1228, (01)00884838099241(21)784, (01)00884838099241(21)1160, (01)00884838099241(21)1184, (01)00884838099241(21)1063, (01)00884838099241(21)1252, (01)00884838099241(21)1079, (01)00884838099241(21)1235, (01)00884838099241(21)1229, (01)00884838099241(21)1298, (01)00884838099241(21)1158, (01)00884838099241(21)993, (01)00884838099241(21)1230, (01)00884838099241(21)1257, (01)00884838099241(21)1209, (01)00884838099241(21)1201, (01)00884838099241(21)1202, (01)00884838099241(21)1157, (01)00884838099241(21)1216, (01)00884838099241(21)1238, (01)00884838099241(21)1233, (01)00884838099241(21)952, (01)00884838099241(21)1200, (01)00884838099241(21)1208, (01)00884838099241(21)1224, (01)00884838099241(21)1260, (01)00884838099241(21)1096, (01)00884838099241(21)1215]; 722233 [(01)00884838116764(21)169, (01)00884838116764(21)96, (01)00884838116764(21)144, (01)00884838116764(21)153, (01)00884838116764(21)259, (01)00884838116764(21)118, (01)00884838116764(21)214, (01)00884838116764(21)41, (01)00884838116764(21)124, (01)00884838116764(21)147, (01)00884838116764(21)103, (01)00884838116764(21)111, (01)00884838116764(21)172, (01)00884838116764(21)192, (01)00884838116764(21)250, (01)00884838116764(21)123, (01)00884838116764(21)37, (01)00884838116764(21)38, (01)00884838116764(21)183, (01)00884838116764(21)17, (01)00884838116764(21)76, (01)00884838116764(21)137, (01)00884838116764(21)12, (01)00884838116764(21)201, (01)00884838116764(21)238, (01)00884838116764(21)82, (01)00884838116764(21)245, (01)00884838116764(21)141, (01)00884838116764(21)27, (01)00884838116764(21)235, (01)00884838116764(21)14, (01)00884838116764(21)138, (01)00884838116764(21)139, (01)00884838116764(21)117, (01)00884838116764(21)7, (01)00884838116764(21)31, (01)00884838116764(21)165, (01)00884838116764(21)166, (01)00884838116764(21)62, (01)00884838116764(21)95, (01)00884838116764(21)100, (01)00884838116764(21)29, (01)00884838116764(21)203, (01)00884838116764(21)204, (01)00884838116764(21)205, (01)00884838116764(21)120, (01)00884838116764(21)181, (01)00884838116764(21)110, (01)00884838116764(21)112, (01)00884838116764(21)173, (01)00884838116764(21)160, (01)00884838116764(21)51, (01)00884838116764(21)202, (01)00884838116764(21)86, (01)00884838116764(21)179, (01)00884838116764(21)197, (01)00884838116764(21)58, (01)00884838116764(21)223, (01)00884838116764(21)211, (01)00884838116764(21)136, (01)00884838116764(21)81, (01)00884838116764(21)16, (01)00884838116764(21)24, (01)00884838116764(21)184, (01)00884838116764(21)129, (01)00884838116764(21)222, (01)00884838116764(21)30, (01)00884838116764(21)134, (01)00884838116764(21)143, (01)00884838116764(21)162, (01)00884838116764(21)71, (01)00884838116764(21)40, (01)00884838116764(21)48, (01)00884838116764(21)101, (01)00884838116764(21)180, (01)00884838116764(21)106, (01)00884838116764(21)133, (01)00884838116764(21)57, (01)00884838116764(21)61, (01)00884838116764(21)145, (01)00884838116764(21)44, (01)00884838116764(21)231, (01)00884838116764(21)85, (01)00884838116764(21)83, (01)00884838116764(21)84, (01)00884838116764(21)87, (01)00884838116764(21)88, (01)00884838116764(21)19, (01)00884838116764(21)5, (01)00884838116764(21)6, (01)00884838116764(21)18, (01)00884838116764(21)257, (01)00884838116764(21)55, (01)00884838116764(21)239, (01)00884838116764(21)240, (01)00884838116764(21)32, (01)00884838116764(21)159, (01)00884838116764(21)217, (01)00884838116764(21)20, (01)00884838116764(21)225, (01)00884838116764(21)50, (01)00884838116764(21)11, (01)00884838116764(21)35, (01)00884838116764(21)46, (01)00884838116764(21)47, (01)00884838116764(21)74, (01)00884838116764(21)43, (01)00884838116764(21)60, (01)00884838116764(21)104, (01)00884838116764(21)78, (01)00884838116764(21)249, (01)00884838116764(21)77, (01)00884838116764(21)80, (01)00884838116764(21)174, (01)00884838116764(21)97, (01)00884838116764(21)102, (01)00884838116764(21)146, (01)00884838116764(21)148, (01)00884838116764(21)149, (01)00884838116764(21)109, (01)00884838116764(21)15, (01)00884838116764(21)13, (01)00884838116764(21)39, (01)00884838116764(21)206, (01)00884838116764(21)67].   10. System Code Description: Azurion 7 M20. Model Number [UDI]: 722079 [(01)00884838099258(21)1576, (01)00884838099258(21)1577, (01)00884838099258(21)3514, (01)00884838099258(21)3314, (01)00884838099258(21)3291, (01)00884838099258(21)3155, (01)00884838099258(21)2800, (01)00884838099258(21)2801, (01)00884838099258(21)3697, (01)00884838099258(21)3642, (01)00884838099258(21)2786, (01)00884838099258(21)3393, (01)00884838099258(21)3336, (01)00884838099258(21)3490, (01)00884838099258(21)3582, (01)00884838099258(21)3043, (01)00884838099258(21)3302, (01)00884838099258(21)3305, (01)00884838099258(21)3273, (01)00884838099258(21)3510, (01)00884838099258(21)3354, (01)00884838099258(21)3453, (01)00884838099258(21)2912, (01)00884838099258(21)2873, (01)00884838099258(21)3158, (01)00884838099258(21)2830, (01)00884838099258(21)3283, (01)00884838099258(21)3345, (01)00884838099258(21)3578, (01)00884838099258(21)3564, (01)00884838099258(21)3376, (01)00884838099258(21)3373, (01)00884838099258(21)3398, (01)00884838099258(21)3146, (01)00884838099258(21)3486, (01)00884838099258(21)3219, (01)00884838099258(21)3337, (01)00884838099258(21)1101, (01)00884838099258(21)3023, (01)008848380992. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "SourceCitation",
        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2170-2026&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2170-2026&lang=eng"
        }
      },
      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2170-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2170-2026 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2170-2026&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2170-2026&lang=eng"
        }
      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2170-2026/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
    }
  ],
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      "name": "FDA recall details — Z-2170-2026",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2170-2026",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2026-03-31",
            "Status": "recorded"
          }
        },
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Model Number [UDI]: 722222 [(01)00884838099210(21)358, (01)00884838099210(21)328, (01)00884838099210(21)389, (01)00884838099210(21)378, (01)00884838099210(21)243, (01)00884838099210(21)392, (01)00884838099210(21)396, (01)00884838099210(21)13, (01)00884838099210(21)379, (01)00884838099210(21)385, (01)00884838099210(21)376, (01)00884838099210(21)366, (01)00884838099210(21)365, (01)00884838099210(21)398, (01)00884838099210(21)274]; 722230 [(01)00884838116733(21)40, (01)00884838116733(21)2, (01)00884838116733(21)41, (01)00884838116733(21)15, (01)00884838116733(21)28, (01)00884838116733(21)38, (01)00884838116733(21)9, (01)00884838116733(21)27, (01)00884838116733(21)13].  3. System Code Description: Azurion 5. Model Number [UDI]: 722281 [(01)00884838110564(21)401, (01)00884838110564(21)427, (01)00884838110564(21)382, (01)00884838110564(21)425].  4. System Code Description: Azurion 5 M12. Model Number [UDI]:  722227 [(01)00884838099227(21)265, (01)00884838099227(21)360, (01)00884838099227(21)320, (01)00884838099227(21)338, (01)00884838099227(21)324, (01)00884838099227(21)305, (01)00884838099227(21)356, (01)00884838099227(21)346, (01)00884838099227(21)313, (01)00884838099227(21)339, (01)00884838099227(21)321, (01)00884838099227(21)247, (01)00884838099227(21)298, (01)00884838099227(21)337, (01)00884838099227(21)306, (01)00884838099227(21)336, (01)00884838099227(21)318, (01)00884838099227(21)353, (01)00884838099227(21)309, (01)00884838099227(21)310, (01)00884838099227(21)316, (01)00884838099227(21)272, (01)00884838099227(21)345, (01)00884838099227(21)351, (01)00884838099227(21)352, (01)00884838099227(21)258, (01)00884838099227(21)326, (01)00884838099227(21)348, (01)00884838099227(21)355, (01)00884838099227(21)315, (01)00884838099227(21)280, (01)00884838099227(21)300, (01)00884838099227(21)335, (01)00884838099227(21)344, (01)00884838099227(21)308, (01)00884838099227(21)362, (01)00884838099227(21)323, (01)00884838099227(21)331, (01)00884838099227(21)269, (01)00884838099227(21)294, (01)00884838099227(21)342, (01)00884838099227(21)330, (01)00884838099227(21)340, (01)00884838099227(21)284, (01)00884838099227(21)333, (01)00884838099227(21)253, (01)00884838099227(21)301, (01)00884838099227(21)332, (01)00884838099227(21)334, (01)00884838099227(21)297, (01)00884838099227(21)350, (01)00884838099227(21)307, (01)00884838099227(21)311, (01)00884838099227(21)319, (01)00884838099227(21)286, (01)00884838099227(21)329, (01)00884838099227(21)208, (01)00884838099227(21)178]; 722231 [(01)00884838116740(21)52, (01)00884838116740(21)49, (01)00884838116740(21)50, (01)00884838116740(21)41, (01)00884838116740(21)21, (01)00884838116740(21)53, (01)00884838116740(21)47, (01)00884838116740(21)3, (01)00884838116740(21)25, (01)00884838116740(21)34, (01)00884838116740(21)61, (01)00884838116740(21)26, (01)00884838116740(21)7, (01)00884838116740(21)8, (01)00884838116740(21)4, (01)00884838116740(21)5, (01)00884838116740(21)12, (01)00884838116740(21)60, (01)00884838116740(21)28, (01)00884838116740(21)45, (01)00884838116740(21)20, (01)00884838116740(21)19, (01)00884838116740(21)51, (01)00884838116740(21)29, (01)00884838116740(21)27, (01)00884838116740(21)11, (01)00884838116740(21)35, (01)00884838116740(21)62, (01)00884838116740(21)54, (01)00884838116740(21)33, (01)00884838116740(21)1, (01)00884838116740(21)2, (01)00884838116740(21)32].    5. 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(01)00884838110564(21)163, (01)00884838110564(21)111, (01)00884838110564(21)252, (01)00884838110564(21)230, (01)00884838110564(21)42, (01)00884838110564(21)213, (01)00884838110564(21)220, (01)00884838110564(21)25, (01)00884838110564(21)106, (01)00884838110564(21)142, (01)00884838110564(21)84, (01)00884838110564(21)16, (01)00884838110564(21)431, (01)00884838110564(21)257, (01)00884838110564(21)241, (01)00884838110564(21)243, (01)00884838110564(21)165, (01)00884838110564(21)147, (01)00884838110564(21)248, (01)00884838110564(21)288].   6. System Code Description: Azurion 7. Model Number [UDI]: 722282 [(01)00884838110571(21)144, (01)00884838110571(21)92, (01)00884838110571(21)123].   7. System Code Description: Azurion 7 B12. Model Number [UDI]: 722225 [(01)00884838099265(21)400, (01)00884838099265(21)453, (01)00884838099265(21)434, (01)00884838099265(21)435, (01)00884838099265(21)409, (01)00884838099265(21)455, (01)00884838099265(21)468, (01)00884838099265(21)462, (01)00884838099265(21)431, (01)00884838099265(21)450, (01)00884838099265(21)460, (01)00884838099265(21)469, (01)00884838099265(21)470, (01)00884838099265(21)437, (01)00884838099265(21)465, (01)00884838099265(21)457, (01)00884838099265(21)461, (01)00884838099265(21)426, (01)00884838099265(21)454, (01)00884838099265(21)418, (01)00884838099265(21)438, (01)00884838099265(21)366, (01)00884838099265(21)451, (01)00884838099265(21)452, (01)00884838099265(21)254, (01)00884838099265(21)392, (01)00884838099265(21)456, (01)00884838099265(21)442, (01)00884838099265(21)447, (01)00884838099265(21)446, (01)00884838099265(21)448, (01)00884838099265(21)459, (01)00884838099265(21)439, (01)00884838099265(21)471, (01)00884838099265(21)472, (01)00884838099265(21)251, (01)00884838099265(21)253, (01)00884838099265(21)441, (01)00884838099265(21)411, (01)00884838099265(21)252, (01)00884838099265(21)1, (01)00884838099265(21)396, (01)00884838099265(21)178, (01)00884838099265(21)445]; 722235 [(01)00884838116788(21)77, (01)00884838116788(21)76, (01)00884838116788(21)102, (01)00884838116788(21)59, (01)00884838116788(21)71, (01)00884838116788(21)11, (01)00884838116788(21)13, (01)00884838116788(21)41, (01)00884838116788(21)94, (01)00884838116788(21)70, (01)00884838116788(21)54, (01)00884838116788(21)47, (01)00884838116788(21)79, (01)00884838116788(21)93, (01)00884838116788(21)72, (01)00884838116788(21)27, (01)00884838116788(21)14, (01)00884838116788(21)20, (01)00884838116788(21)56, (01)00884838116788(21)30, (01)00884838116788(21)31, (01)00884838116788(21)10, (01)00884838116788(21)3, (01)00884838116788(21)99, (01)00884838116788(21)82, (01)00884838116788(21)83, (01)00884838116788(21)84, (01)00884838116788(21)100, (01)00884838116788(21)66, (01)00884838116788(21)67, (01)00884838116788(21)96, (01)00884838116788(21)63, (01)00884838116788(21)34, (01)00884838116788(21)28, (01)00884838116788(21)17, (01)00884838116788(21)18, (01)00884838116788(21)65, (01)00884838116788(21)40, (01)00884838116788(21)45, (01)00884838116788(21)44, (01)00884838116788(21)42, (01)00884838116788(21)52, (01)00884838116788(21)49, (01)00884838116788(21)101, (01)00884838116788(21)53, (01)00884838116788(21)81, (01)00884838116788(21)25, (01)00884838116788(21)24, (01)00884838116788(21)6, (01)00884838116788(21)38, (01)00884838116788(21)39, (01)00884838116788(21)7, (01)00884838116788(21)5, (01)00884838116788(21)8, (01)00884838116788(21)58, (01)00884838116788(21)111, (01)00884838116788(21)98, (01)00884838116788(21)64, (01)00884838116788(21)9, (01)00884838116788(21)35, (01)00884838116788(21)19, (01)00884838116788(21)23, (01)00884838116788(21)21, (01)00884838116788(21)33].   8. System Code Description: Azurion 7 B20. Model Number [UDI]: 722068 [(01)00884838085367(21)113]; 722226 [(01)00884838099272(21)1052, (01)00884838099272(21)1091, (01)00884838099272(21)1078, (01)00884838099272(21)1145, (01)00884838099272(21)891, (01)00884838099272(21)1021, (01)00884838099272(21)955, (01)00884838099272(21)683, (01)00884838099272(21)1017, (01)00884838099272(21)894, (01)00884838099272(21)973, (01)00884838099272(21)1125, (01)00884838099272(21)987, (01)00884838099272(21)1050, (01)00884838099272(21)1139, (01)00884838099272(21)1062, (01)00884838099272(21)1121, (01)00884838099272(21)1046, (01)00884838099272(21)1083, (01)00884838099272(21)1126, (01)00884838099272(21)977, (01)00884838099272(21)1113, (01)00884838099272(21)1043, (01)00884838099272(21)797, (01)00884838099272(21)1097, (01)00884838099272(21)1094, (01)00884838099272(21)1107, (01)00884838099272(21)1092, (01)00884838099272(21)1143, (01)00884838099272(21)1073, (01)00884838099272(21)1027, (01)00884838099272(21)1067, (01)00884838099272(21)1114, (01)00884838099272(21)1102, (01)00884838099272(21)1060, (01)00884838099272(21)972, (01)00884838099272(21)1136, (01)00884838099272(21)944, (01)00884838099272(21)1123, (01)00884838099272(21)1039, (01)00884838099272(21)1049, (01)00884838099272(21)909, (01)00884838099272(21)754, (01)00884838099272(21)1057, (01)00884838099272(21)911, (01)00884838099272(21)1103, (01)00884838099272(21)1069, (01)00884838099272(21)1076, (01)00884838099272(21)1054, (01)00884838099272(21)1048, (01)00884838099272(21)1132, (01)00884838099272(21)548, (01)00884838099272(21)895, (01)00884838099272(21)1087, (01)00884838099272(21)956, (01)00884838099272(21)1077, (01)00884838099272(21)1072, (01)00884838099272(21)1026, (01)00884838099272(21)1129, (01)00884838099272(21)1144, (01)00884838099272(21)1041, (01)00884838099272(21)1053, (01)00884838099272(21)1071, (01)00884838099272(21)1099, (01)00884838099272(21)552, (01)00884838099272(21)1047, (01)00884838099272(21)1127, (01)00884838099272(21)1115, (01)00884838099272(21)699, (01)00884838099272(21)1064, (01)00884838099272(21)1137, (01)00884838099272(21)1111, (01)00884838099272(21)1075, (01)00884838099272(21)1023, (01)00884838099272(21)1135, (01)00884838099272(21)1036, (01)00884838099272(21)1104, (01)00884838099272(21)938, (01)00884838099272(21)1066, (01)00884838099272(21)939, (01)00884838099272(21)1065, (01)00884838099272(21)1038, (01)00884838099272(21)1133, (01)00884838099272(21)1124, (01)00884838099272(21)1022, (01)00884838099272(21)1020, (01)00884838099272(21)1059, (01)00884838099272(21)1118, (01)00884838099272(21)1080, (01)00884838099272(21)1089, (01)00884838099272(21)1035, (01)00884838099272(21)1055, (01)00884838099272(21)532, (01)00884838099272(21)1093, (01)00884838099272(21)1079, (01)00884838099272(21)1106, (01)00884838099272(21)546, (01)00884838099272(21)1058, (01)00884838099272(21)1032, (01)00884838099272(21)3, (01)00884838099272(21)1034]; 722236 [(01)00884838116801(21)37, (01)00884838116801(21)24, (01)00884838116801(21)212, (01)00884838116801(21)25, (01)00884838116801(21)227, (01)00884838116801(21)235, (01)00884838116801(21)226, (01)00884838116801(21)26, (01)00884838116801(21)20, (01)00884838116801(21)249, (01)00884838116801(21)208, (01)00884838116801(21)42, (01)00884838116801(21)205, (01)00884838116801(21)36, (01)00884838116801(21)183, (01)00884838116801(21)133, (01)00884838116801(21)31, (01)00884838116801(21)194, (01)00884838116801(21)158, (01)00884838116801(21)99, (01)00884838116801(21)21, (01)00884838116801(21)40, (01)00884838116801(21)118, (01)00884838116801(21)39, (01)00884838116801(21)233, (01)00884838116801(21)48, (01)00884838116801(21)197, (01)00884838116801(21)221, (01)00884838116801(21)68, (01)00884838116801(21)230, (01)00884838116801(21)38, (01)00884838116801(21)22, (01)00884838116801(21)186, (01)00884838116801(21)134, (01)00884838116801(21)330, (01)00884838116801(21)357, (01)00884838116801(21)289, (01)00884838116801(21)67, (01)00884838116801(21)242, (01)00884838116801(21)223, (01)00884838116801(21)13, (01)00884838116801(21)215, (01)00884838116801(21)348, (01)00884838116801(21)244, (01)00884838116801(21)117, (01)00884838116801(21)201, (01)00884838116801(21)278, (01)00884838116801(21)271, (01)00884838116801(21)34, (01)00884838116801(21)122, (01)00884838116801(21)162, (01)00884838116801(21)93, (01)00884838116801(21)207, (01)00884838116801(21)232, (01)00884838116801(21)216, (01)00884838116801(21)219, (01)00884838116801(21)56, (01)00884838116801(21)57, (01)00884838116801(21)91, (01)00884838116801(21)44, (01)00884838116801(21)234, (01)00884838116801(21)156, (01)00884838116801(21)274, (01)00884838116801(21)237, (01)00884838116801(21)113, (01)00884838116801(21)46, (01)00884838116801(21)292, (01)00884838116801(21)66, (01)00884838116801(21)165, (01)00884838116801(21)163, (01)00884838116801(21)283, (01)00884838116801(21)284, (01)00884838116801(21)285, (01)00884838116801(21)193, (01)00884838116801(21)297, (01)00884838116801(21)269, (01)00884838116801(21)102, (01)00884838116801(21)132, (01)00884838116801(21)157, (01)00884838116801(21)98, (01)00884838116801(21)189, (01)00884838116801(21)30, (01)00884838116801(21)146, (01)00884838116801(21)125, (01)00884838116801(21)182, (01)00884838116801(21)329, (01)00884838116801(21)100, (01)00884838116801(21)123, (01)00884838116801(21)23, (01)00884838116801(21)96, (01)00884838116801(21)181, (01)00884838116801(21)188, (01)00884838116801(21)258, (01)00884838116801(21)130, (01)00884838116801(21)114, (01)00884838116801(21)154, (01)00884838116801(21)264, (01)00884838116801(21)126, (01)00884838116801(21)128, (01)00884838116801(21)86, (01)00884838116801(21)94, (01)00884838116801(21)160, (01)00884838116801(21)170, (01)00884838116801(21)82, (01)00884838116801(21)63, (01)00884838116801(21)268, (01)00884838116801(21)277, (01)00884838116801(21)111, (01)00884838116801(21)172, (01)00884838116801(21)112, (01)00884838116801(21)259, (01)00884838116801(21)103, (01)00884838116801(21)75, (01)00884838116801(21)84, (01)00884838116801(21)52, (01)00884838116801(21)73, (01)00884838116801(21)80, (01)00884838116801(21)175, (01)00884838116801(21)305, (01)00884838116801(21)92, (01)00884838116801(21)155, (01)00884838116801(21)55, (01)00884838116801(21)85, (01)00884838116801(21)142, (01)00884838116801(21)105, (01)00884838116801(21)108, (01)00884838116801(21)53, (01)00884838116801(21)144, (01)00884838116801(21)198, (01)00884838116801(21)141, (01)00884838116801(21)299, (01)00884838116801(21)124, (01)00884838116801(21)62, (01)00884838116801(21)261, (01)00884838116801(21)88, (01)00884838116801(21)89, (01)00884838116801(21)83, (01)00884838116801(21)171, (01)00884838116801(21)240, (01)00884838116801(21)76, (01)00884838116801(21)106, (01)00884838116801(21)90, (01)00884838116801(21)251, (01)00884838116801(21)49, (01)00884838116801(21)74, (01)00884838116801(21)78, (01)00884838116801(21)59, (01)00884838116801(21)104, (01)00884838116801(21)70, (01)00884838116801(21)107, (01)00884838116801(21)64, (01)00884838116801(21)151, (01)00884838116801(21)152, (01)00884838116801(21)69, (01)00884838116801(21)153].   9. System Code Description: Azurion 7 M12. Model Number [UDI]: 722078 [(01)00884838085251(21)1082]; 722223 [(01)00884838099241(21)1038, (01)00884838099241(21)1052, (01)00884838099241(21)1130, (01)00884838099241(21)855, (01)00884838099241(21)1051, (01)00884838099241(21)1241, (01)00884838099241(21)1107, (01)00884838099241(21)1015, (01)00884838099241(21)1231, (01)00884838099241(21)1067, (01)00884838099241(21)1113, (01)00884838099241(21)850, (01)00884838099241(21)1242, (01)00884838099241(21)1211, (01)00884838099241(21)1132, (01)00884838099241(21)1061, (01)00884838099241(21)1296, (01)00884838099241(21)835, (01)00884838099241(21)1185, (01)00884838099241(21)1188, (01)00884838099241(21)1236, (01)00884838099241(21)714, (01)00884838099241(21)1227, (01)00884838099241(21)1264, (01)00884838099241(21)1226, (01)00884838099241(21)1210, (01)00884838099241(21)1290, (01)00884838099241(21)1293, (01)00884838099241(21)1131, (01)00884838099241(21)1282, (01)00884838099241(21)1325, (01)00884838099241(21)1245, (01)00884838099241(21)1214, (01)00884838099241(21)1232, (01)00884838099241(21)1248, (01)00884838099241(21)1256, (01)00884838099241(21)963, (01)00884838099241(21)1222, (01)00884838099241(21)1217, (01)00884838099241(21)1272, (01)00884838099241(21)1283, (01)00884838099241(21)1196, (01)00884838099241(21)1258, (01)00884838099241(21)1212, (01)00884838099241(21)1243, (01)00884838099241(21)1295, (01)00884838099241(21)1125, (01)00884838099241(21)1284, (01)00884838099241(21)1251, (01)00884838099241(21)1271, (01)00884838099241(21)978, (01)00884838099241(21)1276, (01)00884838099241(21)1262, (01)00884838099241(21)1263, (01)00884838099241(21)1247, (01)00884838099241(21)1147, (01)00884838099241(21)1237, (01)00884838099241(21)1301, (01)00884838099241(21)1011, (01)00884838099241(21)1267, (01)00884838099241(21)1246, (01)00884838099241(21)1259, (01)00884838099241(21)1261, (01)00884838099241(21)1291, (01)00884838099241(21)1289, (01)00884838099241(21)1285, (01)00884838099241(21)418, (01)00884838099241(21)759, (01)00884838099241(21)1280, (01)00884838099241(21)1275, (01)00884838099241(21)1268, (01)00884838099241(21)1092, (01)00884838099241(21)6, (01)00884838099241(21)1286, (01)00884838099241(21)1117, (01)00884838099241(21)1239, (01)00884838099241(21)985, (01)00884838099241(21)1186, (01)00884838099241(21)481, (01)00884838099241(21)828, (01)00884838099241(21)1250, (01)00884838099241(21)1270, (01)00884838099241(21)766, (01)00884838099241(21)1172, (01)00884838099241(21)1310, (01)00884838099241(21)1253, (01)00884838099241(21)1254, (01)00884838099241(21)1304, (01)00884838099241(21)1287, (01)00884838099241(21)1288, (01)00884838099241(21)1198, (01)00884838099241(21)1317, (01)00884838099241(21)1302, (01)00884838099241(21)1128, (01)00884838099241(21)1321, (01)00884838099241(21)1322, (01)00884838099241(21)935, (01)00884838099241(21)1218, (01)00884838099241(21)1225, (01)00884838099241(21)1228, (01)00884838099241(21)784, (01)00884838099241(21)1160, (01)00884838099241(21)1184, (01)00884838099241(21)1063, (01)00884838099241(21)1252, (01)00884838099241(21)1079, (01)00884838099241(21)1235, (01)00884838099241(21)1229, (01)00884838099241(21)1298, (01)00884838099241(21)1158, (01)00884838099241(21)993, (01)00884838099241(21)1230, (01)00884838099241(21)1257, (01)00884838099241(21)1209, (01)00884838099241(21)1201, (01)00884838099241(21)1202, (01)00884838099241(21)1157, (01)00884838099241(21)1216, (01)00884838099241(21)1238, (01)00884838099241(21)1233, (01)00884838099241(21)952, (01)00884838099241(21)1200, (01)00884838099241(21)1208, (01)00884838099241(21)1224, (01)00884838099241(21)1260, (01)00884838099241(21)1096, (01)00884838099241(21)1215]; 722233 [(01)00884838116764(21)169, (01)00884838116764(21)96, (01)00884838116764(21)144, (01)00884838116764(21)153, (01)00884838116764(21)259, (01)00884838116764(21)118, (01)00884838116764(21)214, (01)00884838116764(21)41, (01)00884838116764(21)124, (01)00884838116764(21)147, (01)00884838116764(21)103, (01)00884838116764(21)111, (01)00884838116764(21)172, (01)00884838116764(21)192, (01)00884838116764(21)250, (01)00884838116764(21)123, (01)00884838116764(21)37, (01)00884838116764(21)38, (01)00884838116764(21)183, (01)00884838116764(21)17, (01)00884838116764(21)76, (01)00884838116764(21)137, (01)00884838116764(21)12, (01)00884838116764(21)201, (01)00884838116764(21)238, (01)00884838116764(21)82, (01)00884838116764(21)245, (01)00884838116764(21)141, (01)00884838116764(21)27, (01)00884838116764(21)235, (01)00884838116764(21)14, (01)00884838116764(21)138, (01)00884838116764(21)139, (01)00884838116764(21)117, (01)00884838116764(21)7, (01)00884838116764(21)31, (01)00884838116764(21)165, (01)00884838116764(21)166, (01)00884838116764(21)62, (01)00884838116764(21)95, (01)00884838116764(21)100, (01)00884838116764(21)29, (01)00884838116764(21)203, (01)00884838116764(21)204, (01)00884838116764(21)205, (01)00884838116764(21)120, (01)00884838116764(21)181, (01)00884838116764(21)110, (01)00884838116764(21)112, (01)00884838116764(21)173, (01)00884838116764(21)160, (01)00884838116764(21)51, (01)00884838116764(21)202, (01)00884838116764(21)86, (01)00884838116764(21)179, (01)00884838116764(21)197, (01)00884838116764(21)58, (01)00884838116764(21)223, (01)00884838116764(21)211, (01)00884838116764(21)136, (01)00884838116764(21)81, (01)00884838116764(21)16, (01)00884838116764(21)24, (01)00884838116764(21)184, (01)00884838116764(21)129, (01)00884838116764(21)222, (01)00884838116764(21)30, (01)00884838116764(21)134, (01)00884838116764(21)143, (01)00884838116764(21)162, (01)00884838116764(21)71, (01)00884838116764(21)40, (01)00884838116764(21)48, (01)00884838116764(21)101, (01)00884838116764(21)180, (01)00884838116764(21)106, (01)00884838116764(21)133, (01)00884838116764(21)57, (01)00884838116764(21)61, (01)00884838116764(21)145, (01)00884838116764(21)44, (01)00884838116764(21)231, (01)00884838116764(21)85, (01)00884838116764(21)83, (01)00884838116764(21)84, (01)00884838116764(21)87, (01)00884838116764(21)88, (01)00884838116764(21)19, (01)00884838116764(21)5, (01)00884838116764(21)6, (01)00884838116764(21)18, (01)00884838116764(21)257, (01)00884838116764(21)55, (01)00884838116764(21)239, (01)00884838116764(21)240, (01)00884838116764(21)32, (01)00884838116764(21)159, (01)00884838116764(21)217, (01)00884838116764(21)20, (01)00884838116764(21)225, (01)00884838116764(21)50, (01)00884838116764(21)11, (01)00884838116764(21)35, (01)00884838116764(21)46, (01)00884838116764(21)47, (01)00884838116764(21)74, (01)00884838116764(21)43, (01)00884838116764(21)60, (01)00884838116764(21)104, (01)00884838116764(21)78, (01)00884838116764(21)249, (01)00884838116764(21)77, (01)00884838116764(21)80, (01)00884838116764(21)174, (01)00884838116764(21)97, (01)00884838116764(21)102, (01)00884838116764(21)146, (01)00884838116764(21)148, (01)00884838116764(21)149, (01)00884838116764(21)109, (01)00884838116764(21)15, (01)00884838116764(21)13, (01)00884838116764(21)39, (01)00884838116764(21)206, (01)00884838116764(21)67].   10. System Code Description: Azurion 7 M20. Model Number [UDI]: 722079 [(01)00884838099258(21)1576, (01)00884838099258(21)1577, (01)00884838099258(21)3514, (01)00884838099258(21)3314, (01)00884838099258(21)3291, (01)00884838099258(21)3155, (01)00884838099258(21)2800, (01)00884838099258(21)2801, (01)00884838099258(21)3697, (01)00884838099258(21)3642, (01)00884838099258(21)2786, (01)00884838099258(21)3393, (01)00884838099258(21)3336, (01)00884838099258(21)3490, (01)00884838099258(21)3582, (01)00884838099258(21)3043, (01)00884838099258(21)3302, (01)00884838099258(21)3305, (01)00884838099258(21)3273, (01)00884838099258(21)3510, (01)00884838099258(21)3354, (01)00884838099258(21)3453, (01)00884838099258(21)2912, (01)00884838099258(21)2873, (01)00884838099258(21)3158, (01)00884838099258(21)2830, (01)00884838099258(21)3283, (01)00884838099258(21)3345, (01)00884838099258(21)3578, (01)00884838099258(21)3564, (01)00884838099258(21)3376, (01)00884838099258(21)3373, (01)00884838099258(21)3398, (01)00884838099258(21)3146, (01)00884838099258(21)3486, (01)00884838099258(21)3219, (01)00884838099258(21)3337, (01)00884838099258(21)1101, (01)00884838099258(21)3023, (01)008848380992",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the country of Canada.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}