{ "@context": { "schema": "https://schema.org/", "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#", "@vocab": "https://schema.org/", "claims": { "@id": "au:claims", "@container": "@list" }, "epistemicStatus": "au:epistemicStatus", "occurred": "au:occurred", "supported": "au:supported", "adjudged": "au:adjudged", "operative": "au:operative", "grounding": "au:grounding", "groundingType": "au:groundingType", "adjudicator": "au:adjudicator", "source": "au:source", "sourceUrl": "au:sourceUrl", "value": "au:value", "claimType": "au:claimType", "reviewStatus": "au:reviewStatus", "commercialInfluence": "au:commercialInfluence", "falsifier": "au:falsifier" }, "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1926-2024.jsonld", "@type": "schema:Dataset", "name": "Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.", "description": "FDA recall Z-1926-2024 — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is recalling Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases. (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-1926-2024&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.", "manufacturer": { "@type": "schema:Organization", "name": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V." } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1926-2024/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-1926-2024: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is recalling Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.", "text": "The FDA logged enforcement record Z-1926-2024: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is voluntarily recalling Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases. — reason: Potential for pressure wave data synchronization from two devices may not be correct.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-05-02. Affected lots/codes: Software Versions 1.2.0, 1.2.1, 1.2.2, 1.2.3, 1.3.0, 1.3.1. Model No. 722467; UDI: (01)00884838100084 (11)200826(10)5.2.0.0, (01)00884838101180(21)616, (01)00884838101180(21)349, (01)00884838101180(21)2111600488, (01)00884838101180(21)2111601116, (01)00884838101180(21)482, (01)00884838101180(21)412, (01)00884838101180(21)2111601659, (01)00884838101180(21)2111601041, (01)00884838101180(21)2111601582, (01)00884838101180(21)251, (01)00884838101180(21)934, (01)00884838101180(21)305, (01)00884838101180(21)295, (01)00884838101180(21)2111600498, (01)00884838101180(21)217, (01)00884838101180(21)527, (01)00884838101180(21)2111600927, (01)00884838101180(21)247, (01)00884838101180(21)431, (01)00884838101180(21)2111601322, (01)00884838101180(21)2111600711, (01)00884838101180(21)455, (01)00884838101180(21)256, (01)00884838101180(21)268, (01)00884838101180(21)744, (01)00884838101180(21)795, (01)00884838101180(21)800, (01)00884838101180(21)64, (01)00884838101180(21)2111601489, (01)00884838101180(21)685, (01)00884838101180(21)2111600884, (01)00884838101180(21)2111600887, (01)00884838101180(21)629, (01)00884838101180(21)2111600641, (01)00884838101180(21)2111601079, (01)00884838101180(21)2111601443, (01)00884838101180(21)2111601444, (01)00884838101180(21)1104, (01)00884838101180(21)1133, (01)00884838101180(21)812, (01)00884838101180(21)2111601067, (01)00884838101180(21)571, (01)00884838101180(21)2111600465, (01)00884838101180(21)2111600628, (01)00884838101180(21)2111600809, (01)00884838101180(21)1195, (01)00884838101180(21)2111601172, (01)00884838101180(21)2111601176, (01)00884838101180(21)168, (01)00884838101180(21)2111600797, (01)00884838101180(21)2111600664, (01)00884838101180(21)195, (01)00884838101180(21)196, (01)00884838101180(21)780, (01)00884838101180(21)781, (01)00884838101180(21)69, (01)00884838101180(21)2111600764, (01)00884838101180(21)2111601312, (01)00884838101180(21)2111600814, (01)00884838101180(21)42, (01)00884838101180(21)129, (01)00884838101180(21)130, (01)00884838101180(21)2111600936, (01)00884838101180(21)2111600794, (01)00884838101180(21)105, (01)00884838101180(21)2111601478, (01)00884838101180(21)2111600759, (01)00884838101180(21)2111601677, (01)00884838101180(21)2111601338, (01)00884838101180(21)496, (01)00884838101180(21)1155, (01)00884838101180(21)1156, (01)00884838101180(21)2111601612, (01)00884838101180(21)2111601613, (01)00884838101180(21)65, (01)00884838101180(21)62, (01)00884838101180(21)2111601229, (01)00884838101180(21)480, (01)00884838101180(21)983, (01)00884838101180(21)206, (01)00884838101180(21)1151, (01)00884838101180(21)2111600934, (01)00884838101180(21)187, (01)00884838101180(21)2111601628, (01)00884838101180(21)448, (01)00884838101180(21)831, (01)00884838101180(21)832, (01)00884838101180(21)833, (01)00884838101180(21)2111601039, (01)00884838101180(21)970, (01)00884838101180(21)971, (01)00884838101180(21)972, (01)00884838101180(21)973, (01)00884838101180(21)2111601409, (01)00884838101180(21)2111601464, (01)00884838101180(21)2111601357, (01)00884838101180(21)1126, (01)00884838101180(21)357, (01)00884838101180(21)48, (01)00884838101180(21)2111600567, (01)00884838101180(21)2111601040, (01)00884838101180(21)953, (01)00884838101180(21)87, (01)00884838101180(21)259, (01)00884838101180(21)2111600694, (01)00884838101180(21)2111600791, (01)00884838101180(21)2111600924, (01)00884838101180(21)681, (01)00884838101180(21)694, (01)00884838101180(21)24, (01)00884838101180(21)25, (01)00884838101180(21)1088, (01)00884838101180(21)1173, (01)00884838101180(21)2111601091, (01)00884838101180(21)2111600656, (01)00884838101180(21)2111600568, (01)00884838101180(21)2111600578, (01)00884838101180(21)2111600817, (01)00884838101180(21)2111600778, (01)00884838101180(21)324, (01)00884838101180(21)535, (01)00884838101180(21)2111600769, (01)00884838101180(21)2111601672, (01)00884838101180(21)1135, (01)00884838101180(21)2111600433, (01)00884838101180(21)646, (01)00884838101180(21)1140, (01)00884838101180(21)2111601431, (01)00884838101180(21)2111601436, (01)00884838101180(21)2111601437, (01)00884838101180(21)2111601438, (01)00884838101180(21)2111601439, (01)00884838101180(21)889, (01)00884838101180(21)101, (01)00884838101180(21)608, (01)00884838101180(21)609, (01)00884838101180(21)892, (01)00884838101180(21)565, (01)00884838101180(21)821, (01)00884838101180(21)759, (01)00884838101180(21)335, (01)00884838101180(21)1167, (01)00884838101180(21)2111600468, (01)00884838101180(21)7, (01)00884838101180(21)1032, (01)00884838101180(21)1033, (01)00884838101180(21)1160, (01)00884838101180(21)2111601675, (01)00884838101180(21)2111601701, (01)00884838101180(21)2111601702, (01)00884838101180(21)590, (01)00884838101180(21)986, (01)00884838101180(21)987, (01)00884838101180(21)988, (01)00884838101180(21)989, (01)00884838101180(21)990, (01)00884838101180(21)1040, (01)00884838101180(21)2111601143, (01)00884838101180(21)2111601273, (01)00884838101180(21)395, (01)00884838101180(21)2111600551, (01)00884838101180(21)2111600611, (01)00884838101180(21)2111601493, (01)00884838101180(21)2111601494, (01)00884838101180(21)2111601495, (01)00884838101180(21)2111600613, (01)00884838101180(21)2111601221, (01)00884838101180(21)643, (01)00884838101180(21)2111601370, (01)00884838101180(21)729, (01)00884838101180(21)730, (01)00884838101180(21)731, (01)00884838101180(21)2111600635, (01)00884838101180(21)1137, (01)00884838101180(21)1015, (01)00884838101180(21)123, (01)00884838101180(21)124, (01)00884838101180(21)125, (01)00884838101180(21)2111600955, (01)00884838101180(21)2111600956, (01)00884838101180(21)433, (01)00884838101180(21)1106, (01)00884838101180(21)204, (01)00884838101180(21)834, (01)00884838101180(21)2111600684, (01)00884838101180(21)873, (01)00884838101180(21)998, (01)00884838101180(21)2111601213, (01)00884838101180(21)2111601255, (01)00884838101180(21)2111601332, (01)00884838101180(21)2111601323, (01)00884838101180(21)2111601204, (01)00884838101180(21)203, (01)00884838101180(21)2111601706, (01)00884838101180(21)2111601707, (01)00884838101180(21)2, (01)00884838101180(21)3, (01)00884838101180(21)2111601327, (01)00884838101180(21)2111601681, (01)00884838101180(21)262, (01)00884838101180(21)57, (01)00884838101180(21)2111601175, (01)00884838101180(21)150, (01)00884838101180(21)151, (01)00884838101180(21)152, (01)00884838101180(21)138, (01)00884838101180(21)139, (01)00884838101180(21)145, (01)00884838101180(21)156, (01)00884838101180(21)300, (01)00884838101180(21)980, (01)00884838101180(21)2111600495, (01)00884838101180(21)2111601220, (01)00884838101180(21)2111601154, (01)00884838101180(21)2111601798, (01)00884838101180(21)613, (01)00884838101180(21)614, (01)00884838101180(21)2111600763, (01)00884838101180(21)2111601165, (01)00884838101180(21)2111601235, (01)00884838101180(21)283, (01)00884838101180(21)539, (01)00884838101180(21)2111601002, (01)00884838101180(21)182, (01)00884838101180(21)337, (01)00884838101180(21)343, (01)00884838101180(21)344, (01)00884838101180(21)345, (01)00884838101180(21)620, (01)00884838101180(21)2111600445, (01)00884838101180(21)1161, (01)00884838101180(21)86, (01)00884838101180(21)282, (01)00884838101180(21)2111600777, (01)00884838101180(21)2111601725, (01)00884838101180(21)2111601726, (01)00884838101180(21)2111601727, (01)00884838101180(21)2111601728, (01)00884838101180(21)2111600583, (01)00884838101180(21)2111600588, (01)00884838101180(21)2111600589, (01)00884838101180(21)2111600590, (01)00884838101180(21)2111600564, (01)00884838101180(21)655, (01)00884838101180(21)656, (01)00884838101180(21)2111600970, (01)00884838101180(21)132, (01)00884838101180(21)2111601321, (01)00884838101180(21)814, (01)00884838101180(21)575, (01)00884838101180(21)611, (01)00884838101180(21)169, (01)00884838101180(21)191, (01)00884838101180(21)212, (01)00884838101180(21)2111601103, (01)00884838101180(21)2111601104, (01)00884838101180(21)146, (01)00884838101180(21)2111601584, (01)00884838101180(21)948, (01)00884838101180(21)2111601253, (01)00884838101180(21)1147, (01)00884838101180(21)490, (01)00884838101180(21)2111600614, (01)00884838101180(21)2111601550, (01)00884838101180(21)207, (01)00884838101180(21)1141, (01)00884838101180(21)157, (01)00884838101180(21)598, (01)00884838101180(21)2111601248, (01)00884838101180(21)2111600451, (01)00884838101180(21)192, (01)00884838101180(21)188, (01)00884838101180(21)189, (01)00884838101180(21)190, (01)00884838101180(21)2111600692, (01)00884838101180(21)2111600963, (01)00884838101180(21)2111600964, (01)00884838101180(21)2111600965, (01)00884838101180(21)2111600966, (01)00884838101180(21)763, (01)00884838101180(21)776, (01)00884838101180(21)263, (01)00884838101180(21)1020, (01)00884838101180(21)1021, (01)00884838101180(21)1022, (01)00884838101180(21)841, (01)00884838101180(21)2111600651, (01)00884838101180(21)310, (01)00884838101180(21)311, (01)00884838101180(21)2111600824, (01)00884838101180(21)2111600825, (01)00884838101180(21)278, (01)00884838101180(21)373, (01)00884838101180(21)2111600693, (01)00884838101180(21)93, (01)00884838101180(21)612, (01)00884838101180(21)11, (01)00884838101180(21)186, (01)00884838101180(21)793, (01)00884838101180(21)706, (01)00884838101180(21)2111600659, (01)00884838101180(21)2111600660, (01)00884838101180(21)653, (01)00884838101180(21)961, (01)00884838101180(21)2111601446, (01)00884838101180(21)898, (01)00884838101180(21)665, (01)00884838101180(21)2111600627, (01)00884838101180(21)2111600463, (01)00884838101180(21)662, (01)00884838101180(21)1086, (01)00884838101180(21)1162, (01)00884838101180(21)2111600541, (01)00884838101180(21)2111600479, (01)00884838101180(21)2111600480, (01)00884838101180(21)2111601720, (01)00884838101180(21)530, (01)00884838101180(21)607, (01)00884838101180(21)339, (01)00884838101180(21)2111601054, (01)00884838101180(21)119, (01)00884838101180(21)120, (01)00884838101180(21)2111600658, (01)00884838101180(21)756, (01)00884838101180(21)2111600992, (01)00884838101180(21)720, (01)00884838101180(21)633, (01)00884838101180(21)725, (01)00884838101180(21)377, (01)00884838101180(21)384, (01)00884838101180(21)2111600602, (01)00884838101180(21)2111600668, (01)00884838101180(21)2111601652, (01)00884838101180(21)2111600560, (01)00884838101180(21)2111600846, (01)00884838101180(21)599, (01)00884838101180(21)491, (01)00884838101180(21)288, (01)00884838101180(21)950, (01)00884838101180(21)606, (01)00884838101180(21)143, (01)00884838101180(21)667, (01)00884838101180(21)135, (01)00884838101180(21)1039, (01)00884838101180(21)82, (01)00884838101180(21)2111600525, (01)00884838101180(21)2111600530, (01)00884838101180(21)2111601250, (01)00884838101180(21)159, (01)00884838101180(21)2111600499, (01)00884838101180(21)468, (01)00884838101180(21)2111601547, (01)00884838101180(21)658, (01)00884838101180(21)2111601319, (01)00884838101180(21)1037, , (01)00884838101180(21)600, (01)00884838101180(21)1197, (01)00884838101180(21)83, (01)00884838101180(21)78, (01)00884838101180(21)2111600545, (01)00884838101180(21)2111600554, (01)00884838101180(21)2111601249, (01)00884838101180(21)1007, (01)00884838101180(21)2111601688; Serial No: CZC9509HWC, CZC950919K, CZC9509HTZ, CZC112CW4W, 3203, 616, MXL2342FBK, MXL2342F9N, MXL2342F9D, MXL221294Q, MXL221294Z, CZC12095LJ, CZC12175YY, MXL221293R, MXL221293Y, MXL2342F16, MXL2342FOC, MXL2342FB4, MXL2342FB9, MXL2342F9K, CZC1088DDM, CZC1099NF4, MXL3362KYB, CZC1077045, CZC107704M, CZC1077043, CZC107705D, 349, 2111600488, 2111601116, 482, 412, 2111601659, 2111601041, 2111601582, 251, 934, 305, 295, 2111600498, 217, 527, 2111600927, 247, 431, 2111601322, 2111600711, 455, 256, 268, 744, 795, 800, 64, 2111601489, 685, 2111600884, 2111600887, 629, 2111600641, 2111601079, 2111601443, 2111601444, 1104, 1133, 812, 2111601067, 571, 2111600465, 2111600628, 2111600809, 1195, 2111601172, 2111601176, 168, 2111600797, 2111600664, 195, 196, 780, 781, 69, 2111600764, 2111601312, 2111600814, 42, 129, 130, 2111600936, 2111600794, 105, 2111601478, 2111600759, 2111601677, 2111601338, 496, 1155, 1156, 2111601612, 2111601613, 65, 62, 2111601229, 480, 983, 206, 1151, 2111600934, 187, 2111601628, 448, 831, 832, 833, 2111601039, 970, 971, 972, 973, 2111601409, 2111601464, 2111601357, 1126, 357, 48, 2111600567, 2111601040, 953, 87, 259, 2111600694, 2111600791, 2111600924, 681, 694, 24, 25, 1088, 1173, 2111601091, 2111600656, 2111600568, 2111600578, 2111600817, 2111600778, 324, 535, 2111600769, 2111601672, 1135, 2111600433, 646, 1140, 2111601431, 2111601436, 2111601437, 2111601438, 2111601439, 889, 101, 608, 609, 892, 565, 821, 759, 335, 1167, 2111600468, 7, 1032, 1033, 1160, 2111601675, 2111601701, 2111601702, 590, 986, 987, 988, 989, 990, 1040, 2111601143, 2111601273, 395, 2111600551, 2111600611, 2111601493, 2111601494, 2111601495, 2111600613, 2111601221, 643, 2111601370, 729, 730, 731, 2111600635, 1137, 1015, 123, 124, 125, 2111600955, 2111600956, 433, 1106, 204, 834, 2111600684, 873, 998, 2111601213, 2111601255, 2111601332, 2111601323, 2111601204, 203, 2111601706, 2111601707, 2, 3, 2111601327, 2111601681, 262, 57, 2111601175, 150, 151, 152, 138, 139, 145, 156, 300, 980, 2111600495, 2111601220, 2111601154, 2111601798, 613, 614, 2111600763, 2111601165, 2111601235, 283, 539, 2111601002, 182, 337, 343, 344, 345, 620, 2111600445, 1161, 86, 282, 2111600777, 2111601725, 2111601726, 2111601727, 2111601728, 2111600583, 2111600588, 2111600589, 2111600590, 2111600564, 655, 656, 2111600970, 132, 2111601321, 814, 575, 611, 169, 191, 212, 2111601103, 2111601104, 146, 2111601584, 948, 2111601253, 1147, 490, 2111600614, 2111601550, 207, 1141, 157, 598, 2111601248, 2111600451, 192, 188, 189, 190, 2111600692, 2111600963, 2111600964, 2111600965, 2111600966, 763, 776, 263, 1020, 1021, 1022, 841, 2111600651, 310, 311, 2111600824, 2111600825, 278, 373, 2111600693, 93, 612, 11, 186, 793, 706, 2111600659, 2111600660, 653, 961, 2111601446, 898, 665, 2111600627, 2111600463, 662, 1086, 1162, 2111600541, 2111600479, 2111600480, 2111601720, 530, 607, 339, 2111601054, 119, 120, 2111600658, 756, 2111600992, 720, 633, 725, 377, 384, 2111600602, 2111600668, 2111601652, 2111600560, 2111600846, 599, 491, 288, 950, 606, 143, 667, 135, 1039, 82, 2111600525, 2111600530, 2111601250, 159, 2111600499, 468, 2111601547, 658, 2111601319, 1037, , 600, 1197, 83, 78, 2111600545, 2111600554, 2111601249, 1007, 2111601688.. 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-1926-2024&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-1926-2024&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-1926-2024/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-1926-2024 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-1926-2024&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-1926-2024&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-1926-2024/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." } ], "hasPart": [ { "@type": "schema:ItemList", "name": "FDA recall details — Z-1926-2024", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-1926-2024", "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 pressure wave data synchronization from two devices may not be correct.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2024-05-02", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "Software Versions 1.2.0, 1.2.1, 1.2.2, 1.2.3, 1.3.0, 1.3.1. Model No. 722467; UDI: (01)00884838100084 (11)200826(10)5.2.0.0, (01)00884838101180(21)616, (01)00884838101180(21)349, (01)00884838101180(21)2111600488, (01)00884838101180(21)2111601116, (01)00884838101180(21)482, (01)00884838101180(21)412, (01)00884838101180(21)2111601659, (01)00884838101180(21)2111601041, (01)00884838101180(21)2111601582, (01)00884838101180(21)251, (01)00884838101180(21)934, (01)00884838101180(21)305, (01)00884838101180(21)295, (01)00884838101180(21)2111600498, (01)00884838101180(21)217, (01)00884838101180(21)527, (01)00884838101180(21)2111600927, (01)00884838101180(21)247, (01)00884838101180(21)431, (01)00884838101180(21)2111601322, (01)00884838101180(21)2111600711, (01)00884838101180(21)455, (01)00884838101180(21)256, (01)00884838101180(21)268, (01)00884838101180(21)744, (01)00884838101180(21)795, (01)00884838101180(21)800, (01)00884838101180(21)64, (01)00884838101180(21)2111601489, (01)00884838101180(21)685, (01)00884838101180(21)2111600884, (01)00884838101180(21)2111600887, (01)00884838101180(21)629, (01)00884838101180(21)2111600641, (01)00884838101180(21)2111601079, (01)00884838101180(21)2111601443, (01)00884838101180(21)2111601444, (01)00884838101180(21)1104, (01)00884838101180(21)1133, (01)00884838101180(21)812, (01)00884838101180(21)2111601067, (01)00884838101180(21)571, (01)00884838101180(21)2111600465, (01)00884838101180(21)2111600628, (01)00884838101180(21)2111600809, (01)00884838101180(21)1195, (01)00884838101180(21)2111601172, (01)00884838101180(21)2111601176, (01)00884838101180(21)168, (01)00884838101180(21)2111600797, (01)00884838101180(21)2111600664, (01)00884838101180(21)195, (01)00884838101180(21)196, (01)00884838101180(21)780, (01)00884838101180(21)781, (01)00884838101180(21)69, (01)00884838101180(21)2111600764, (01)00884838101180(21)2111601312, (01)00884838101180(21)2111600814, (01)00884838101180(21)42, (01)00884838101180(21)129, (01)00884838101180(21)130, (01)00884838101180(21)2111600936, (01)00884838101180(21)2111600794, (01)00884838101180(21)105, (01)00884838101180(21)2111601478, (01)00884838101180(21)2111600759, (01)00884838101180(21)2111601677, (01)00884838101180(21)2111601338, (01)00884838101180(21)496, (01)00884838101180(21)1155, (01)00884838101180(21)1156, (01)00884838101180(21)2111601612, (01)00884838101180(21)2111601613, (01)00884838101180(21)65, (01)00884838101180(21)62, (01)00884838101180(21)2111601229, (01)00884838101180(21)480, (01)00884838101180(21)983, (01)00884838101180(21)206, (01)00884838101180(21)1151, (01)00884838101180(21)2111600934, (01)00884838101180(21)187, (01)00884838101180(21)2111601628, (01)00884838101180(21)448, (01)00884838101180(21)831, (01)00884838101180(21)832, (01)00884838101180(21)833, (01)00884838101180(21)2111601039, (01)00884838101180(21)970, (01)00884838101180(21)971, (01)00884838101180(21)972, (01)00884838101180(21)973, (01)00884838101180(21)2111601409, (01)00884838101180(21)2111601464, (01)00884838101180(21)2111601357, (01)00884838101180(21)1126, (01)00884838101180(21)357, (01)00884838101180(21)48, (01)00884838101180(21)2111600567, (01)00884838101180(21)2111601040, (01)00884838101180(21)953, (01)00884838101180(21)87, (01)00884838101180(21)259, (01)00884838101180(21)2111600694, (01)00884838101180(21)2111600791, (01)00884838101180(21)2111600924, (01)00884838101180(21)681, (01)00884838101180(21)694, (01)00884838101180(21)24, (01)00884838101180(21)25, (01)00884838101180(21)1088, (01)00884838101180(21)1173, (01)00884838101180(21)2111601091, (01)00884838101180(21)2111600656, (01)00884838101180(21)2111600568, (01)00884838101180(21)2111600578, (01)00884838101180(21)2111600817, (01)00884838101180(21)2111600778, (01)00884838101180(21)324, (01)00884838101180(21)535, (01)00884838101180(21)2111600769, (01)00884838101180(21)2111601672, (01)00884838101180(21)1135, (01)00884838101180(21)2111600433, (01)00884838101180(21)646, (01)00884838101180(21)1140, (01)00884838101180(21)2111601431, (01)00884838101180(21)2111601436, (01)00884838101180(21)2111601437, (01)00884838101180(21)2111601438, (01)00884838101180(21)2111601439, (01)00884838101180(21)889, (01)00884838101180(21)101, (01)00884838101180(21)608, (01)00884838101180(21)609, (01)00884838101180(21)892, (01)00884838101180(21)565, (01)00884838101180(21)821, (01)00884838101180(21)759, (01)00884838101180(21)335, (01)00884838101180(21)1167, (01)00884838101180(21)2111600468, (01)00884838101180(21)7, (01)00884838101180(21)1032, (01)00884838101180(21)1033, (01)00884838101180(21)1160, (01)00884838101180(21)2111601675, (01)00884838101180(21)2111601701, (01)00884838101180(21)2111601702, (01)00884838101180(21)590, (01)00884838101180(21)986, (01)00884838101180(21)987, (01)00884838101180(21)988, (01)00884838101180(21)989, (01)00884838101180(21)990, (01)00884838101180(21)1040, (01)00884838101180(21)2111601143, (01)00884838101180(21)2111601273, (01)00884838101180(21)395, (01)00884838101180(21)2111600551, (01)00884838101180(21)2111600611, (01)00884838101180(21)2111601493, (01)00884838101180(21)2111601494, (01)00884838101180(21)2111601495, (01)00884838101180(21)2111600613, (01)00884838101180(21)2111601221, (01)00884838101180(21)643, (01)00884838101180(21)2111601370, (01)00884838101180(21)729, (01)00884838101180(21)730, (01)00884838101180(21)731, (01)00884838101180(21)2111600635, (01)00884838101180(21)1137, (01)00884838101180(21)1015, (01)00884838101180(21)123, (01)00884838101180(21)124, (01)00884838101180(21)125, (01)00884838101180(21)2111600955, (01)00884838101180(21)2111600956, (01)00884838101180(21)433, (01)00884838101180(21)1106, (01)00884838101180(21)204, (01)00884838101180(21)834, (01)00884838101180(21)2111600684, (01)00884838101180(21)873, (01)00884838101180(21)998, (01)00884838101180(21)2111601213, (01)00884838101180(21)2111601255, (01)00884838101180(21)2111601332, (01)00884838101180(21)2111601323, (01)00884838101180(21)2111601204, (01)00884838101180(21)203, (01)00884838101180(21)2111601706, (01)00884838101180(21)2111601707, (01)00884838101180(21)2, (01)00884838101180(21)3, (01)00884838101180(21)2111601327, (01)00884838101180(21)2111601681, (01)00884838101180(21)262, (01)00884838101180(21)57, (01)00884838101180(21)2111601175, (01)00884838101180(21)150, (01)00884838101180(21)151, (01)00884838101180(21)152, (01)00884838101180(21)138, (01)00884838101180(21)139, (01)00884838101180(21)145, (01)00884838101180(21)156, (01)00884838101180(21)300, (01)00884838101180(21)980, (01)00884838101180(21)2111600495, (01)00884838101180(21)2111601220, (01)00884838101180(21)2111601154, (01)00884838101180(21)2111601798, (01)00884838101180(21)613, (01)00884838101180(21)614, (01)00884838101180(21)2111600763, (01)00884838101180(21)2111601165, (01)00884838101180(21)2111601235, (01)00884838101180(21)283, (01)00884838101180(21)539, (01)00884838101180(21)2111601002, (01)00884838101180(21)182, (01)00884838101180(21)337, (01)00884838101180(21)343, (01)00884838101180(21)344, (01)00884838101180(21)345, (01)00884838101180(21)620, (01)00884838101180(21)2111600445, (01)00884838101180(21)1161, (01)00884838101180(21)86, (01)00884838101180(21)282, (01)00884838101180(21)2111600777, (01)00884838101180(21)2111601725, (01)00884838101180(21)2111601726, (01)00884838101180(21)2111601727, (01)00884838101180(21)2111601728, (01)00884838101180(21)2111600583, (01)00884838101180(21)2111600588, (01)00884838101180(21)2111600589, (01)00884838101180(21)2111600590, (01)00884838101180(21)2111600564, (01)00884838101180(21)655, (01)00884838101180(21)656, (01)00884838101180(21)2111600970, (01)00884838101180(21)132, (01)00884838101180(21)2111601321, (01)00884838101180(21)814, (01)00884838101180(21)575, (01)00884838101180(21)611, (01)00884838101180(21)169, (01)00884838101180(21)191, (01)00884838101180(21)212, (01)00884838101180(21)2111601103, (01)00884838101180(21)2111601104, (01)00884838101180(21)146, (01)00884838101180(21)2111601584, (01)00884838101180(21)948, (01)00884838101180(21)2111601253, (01)00884838101180(21)1147, (01)00884838101180(21)490, (01)00884838101180(21)2111600614, (01)00884838101180(21)2111601550, (01)00884838101180(21)207, (01)00884838101180(21)1141, (01)00884838101180(21)157, (01)00884838101180(21)598, (01)00884838101180(21)2111601248, (01)00884838101180(21)2111600451, (01)00884838101180(21)192, (01)00884838101180(21)188, (01)00884838101180(21)189, (01)00884838101180(21)190, (01)00884838101180(21)2111600692, (01)00884838101180(21)2111600963, (01)00884838101180(21)2111600964, (01)00884838101180(21)2111600965, (01)00884838101180(21)2111600966, (01)00884838101180(21)763, (01)00884838101180(21)776, (01)00884838101180(21)263, (01)00884838101180(21)1020, (01)00884838101180(21)1021, (01)00884838101180(21)1022, (01)00884838101180(21)841, (01)00884838101180(21)2111600651, (01)00884838101180(21)310, (01)00884838101180(21)311, (01)00884838101180(21)2111600824, (01)00884838101180(21)2111600825, (01)00884838101180(21)278, (01)00884838101180(21)373, (01)00884838101180(21)2111600693, (01)00884838101180(21)93, (01)00884838101180(21)612, (01)00884838101180(21)11, (01)00884838101180(21)186, (01)00884838101180(21)793, (01)00884838101180(21)706, (01)00884838101180(21)2111600659, (01)00884838101180(21)2111600660, (01)00884838101180(21)653, (01)00884838101180(21)961, (01)00884838101180(21)2111601446, (01)00884838101180(21)898, (01)00884838101180(21)665, (01)00884838101180(21)2111600627, (01)00884838101180(21)2111600463, (01)00884838101180(21)662, (01)00884838101180(21)1086, (01)00884838101180(21)1162, (01)00884838101180(21)2111600541, (01)00884838101180(21)2111600479, (01)00884838101180(21)2111600480, (01)00884838101180(21)2111601720, (01)00884838101180(21)530, (01)00884838101180(21)607, (01)00884838101180(21)339, (01)00884838101180(21)2111601054, (01)00884838101180(21)119, (01)00884838101180(21)120, (01)00884838101180(21)2111600658, (01)00884838101180(21)756, (01)00884838101180(21)2111600992, (01)00884838101180(21)720, (01)00884838101180(21)633, (01)00884838101180(21)725, (01)00884838101180(21)377, (01)00884838101180(21)384, (01)00884838101180(21)2111600602, (01)00884838101180(21)2111600668, (01)00884838101180(21)2111601652, (01)00884838101180(21)2111600560, (01)00884838101180(21)2111600846, (01)00884838101180(21)599, (01)00884838101180(21)491, (01)00884838101180(21)288, (01)00884838101180(21)950, (01)00884838101180(21)606, (01)00884838101180(21)143, (01)00884838101180(21)667, (01)00884838101180(21)135, (01)00884838101180(21)1039, (01)00884838101180(21)82, (01)00884838101180(21)2111600525, (01)00884838101180(21)2111600530, (01)00884838101180(21)2111601250, (01)00884838101180(21)159, (01)00884838101180(21)2111600499, (01)00884838101180(21)468, (01)00884838101180(21)2111601547, (01)00884838101180(21)658, (01)00884838101180(21)2111601319, (01)00884838101180(21)1037, , (01)00884838101180(21)600, (01)00884838101180(21)1197, (01)00884838101180(21)83, (01)00884838101180(21)78, (01)00884838101180(21)2111600545, (01)00884838101180(21)2111600554, (01)00884838101180(21)2111601249, (01)00884838101180(21)1007, (01)00884838101180(21)2111601688; Serial No: CZC9509HWC, CZC950919K, CZC9509HTZ, CZC112CW4W, 3203, 616, MXL2342FBK, MXL2342F9N, MXL2342F9D, MXL221294Q, MXL221294Z, CZC12095LJ, CZC12175YY, MXL221293R, MXL221293Y, MXL2342F16, MXL2342FOC, MXL2342FB4, MXL2342FB9, MXL2342F9K, CZC1088DDM, CZC1099NF4, MXL3362KYB, CZC1077045, CZC107704M, CZC1077043, CZC107705D, 349, 2111600488, 2111601116, 482, 412, 2111601659, 2111601041, 2111601582, 251, 934, 305, 295, 2111600498, 217, 527, 2111600927, 247, 431, 2111601322, 2111600711, 455, 256, 268, 744, 795, 800, 64, 2111601489, 685, 2111600884, 2111600887, 629, 2111600641, 2111601079, 2111601443, 2111601444, 1104, 1133, 812, 2111601067, 571, 2111600465, 2111600628, 2111600809, 1195, 2111601172, 2111601176, 168, 2111600797, 2111600664, 195, 196, 780, 781, 69, 2111600764, 2111601312, 2111600814, 42, 129, 130, 2111600936, 2111600794, 105, 2111601478, 2111600759, 2111601677, 2111601338, 496, 1155, 1156, 2111601612, 2111601613, 65, 62, 2111601229, 480, 983, 206, 1151, 2111600934, 187, 2111601628, 448, 831, 832, 833, 2111601039, 970, 971, 972, 973, 2111601409, 2111601464, 2111601357, 1126, 357, 48, 2111600567, 2111601040, 953, 87, 259, 2111600694, 2111600791, 2111600924, 681, 694, 24, 25, 1088, 1173, 2111601091, 2111600656, 2111600568, 2111600578, 2111600817, 2111600778, 324, 535, 2111600769, 2111601672, 1135, 2111600433, 646, 1140, 2111601431, 2111601436, 2111601437, 2111601438, 2111601439, 889, 101, 608, 609, 892, 565, 821, 759, 335, 1167, 2111600468, 7, 1032, 1033, 1160, 2111601675, 2111601701, 2111601702, 590, 986, 987, 988, 989, 990, 1040, 2111601143, 2111601273, 395, 2111600551, 2111600611, 2111601493, 2111601494, 2111601495, 2111600613, 2111601221, 643, 2111601370, 729, 730, 731, 2111600635, 1137, 1015, 123, 124, 125, 2111600955, 2111600956, 433, 1106, 204, 834, 2111600684, 873, 998, 2111601213, 2111601255, 2111601332, 2111601323, 2111601204, 203, 2111601706, 2111601707, 2, 3, 2111601327, 2111601681, 262, 57, 2111601175, 150, 151, 152, 138, 139, 145, 156, 300, 980, 2111600495, 2111601220, 2111601154, 2111601798, 613, 614, 2111600763, 2111601165, 2111601235, 283, 539, 2111601002, 182, 337, 343, 344, 345, 620, 2111600445, 1161, 86, 282, 2111600777, 2111601725, 2111601726, 2111601727, 2111601728, 2111600583, 2111600588, 2111600589, 2111600590, 2111600564, 655, 656, 2111600970, 132, 2111601321, 814, 575, 611, 169, 191, 212, 2111601103, 2111601104, 146, 2111601584, 948, 2111601253, 1147, 490, 2111600614, 2111601550, 207, 1141, 157, 598, 2111601248, 2111600451, 192, 188, 189, 190, 2111600692, 2111600963, 2111600964, 2111600965, 2111600966, 763, 776, 263, 1020, 1021, 1022, 841, 2111600651, 310, 311, 2111600824, 2111600825, 278, 373, 2111600693, 93, 612, 11, 186, 793, 706, 2111600659, 2111600660, 653, 961, 2111601446, 898, 665, 2111600627, 2111600463, 662, 1086, 1162, 2111600541, 2111600479, 2111600480, 2111601720, 530, 607, 339, 2111601054, 119, 120, 2111600658, 756, 2111600992, 720, 633, 725, 377, 384, 2111600602, 2111600668, 2111601652, 2111600560, 2111600846, 599, 491, 288, 950, 606, 143, 667, 135, 1039, 82, 2111600525, 2111600530, 2111601250, 159, 2111600499, 468, 2111601547, 658, 2111601319, 1037, , 600, 1197, 83, 78, 2111600545, 2111600554, 2111601249, 1007, 2111601688.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "Worldwide distribution - US Nationwide in the states of CA, IN, OR and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Chile, Costa Rica, C¿te D'Ivoire, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hungary, India, Ireland, Italy, Malaysia, Martinique, Netherlands, New Zealand, Oman, Pakistan, Panama, Poland, R¿union, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Sri Lanka, Switzerland, Thailand, Ukraine, United Kingdom.", "Status": "recorded" } } ] } ] }