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  "name": "Brand Name: Atlan  Product Name: Atlan A350XL  Model/Catalog Number: 8621600  Software Version: Not Applicable  Component: Not applicable",
  "description": "FDA recall Z-0305-2025 — Draeger Medical, Inc. is recalling Brand Name: Atlan  Product Name: Atlan A350XL  Model/Catalog Number: 8621600  Software Version: Not Applicable  Component: Not applicable (Devices, Class I). 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.",
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    "name": "Brand Name: Atlan  Product Name: Atlan A350XL  Model/Catalog Number: 8621600  Software Version: Not Applicable  Component: Not applicable",
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0305-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0305-2025: Draeger Medical, Inc. is recalling Brand Name: Atlan  Product Name: Atlan A350XL  Model/Catalog Number: 8621600  Software Version: Not Applicable  Component: Not applicable",
      "text": "The FDA logged enforcement record Z-0305-2025: Draeger Medical, Inc. is voluntarily recalling Brand Name: Atlan  Product Name: Atlan A350XL  Model/Catalog Number: 8621600  Software Version: Not Applicable  Component: Not applicable — reason: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-10-15. Affected lots/codes: Model/Catalog Number: 8621600; UDI-DI Number: 04048675556183; Serial Numbers Distributed in the US: ASTA-0307; 0309; 0311; 0349; 0350; 0351; 0353; 0363; 0365; 0394; 0408; 0409 ASTB-0048; 0286; 0287; 0288; 0289; 0290; 0291; 0304; 0305; 0306; 0307; 0308; 0309; 0317; 0318; 0319; 0320; 0321; 0322 ASTC-0006; 0007; 0068; 0069; 0070; 0082; 0083; 0099; 0100; 0101; 0105; 0106; 0107; 0108; 0109; 0118; 0119; 0136; 0137; 0229; 0230; 0243; 0244; 0245 ASTD-0008; 0009; 0010; 0011; 0012; 0013; 0014; 0129; 0130; 0131; 0132; 0133; 0134; 0135; 0154; 0159; 0160; 0161; 0162; 0163; 0164; 0165; 0166; 0167; 0168; 0169; 0181; 0182; 0183; 0193; 0194; 0195; 0225; 0226; 0227; 0228; 0229; 0230; 0231; 0238; 0239; 0240; 0241; 0242; 0243; 0244; 0245 ASTE-0016; 0017; 0077; 0078; 0079; 0086; 0087; 0122; 0123; 0124; 0125; 0126; 0129; 0130; 0131; 0163; 0164; 0165; 0166; 0171; 0172; 0173; 0174; 0195; 0196; 0197; 0198; 0203; 0225; 0226; 0246; 0247; 0248; 0249; 0250; 0278; 0279; 0280; 0281; 0301; 0302; 0303; 0304; 0305; 0306; 0348; 0349; 0350; 0351; 0352; 0357; 0358; 0359; 0360; 0361; 0362 ASTF-0001; 0002; 0003; 0004; 0014; 0015; 0016; 0017; 0018; 0030; 0031; 0032; 0033; 0034; 0035; 0036; 0037; 0055; 0061; 0062; 0063; 0070; 0071; 0076; 0077; 0078; 0079; 0080; 0081; 0121; 0122; 0123; 0124; 0125; 0135; 0136; 0137; 0138; 0139; 0140; 0141; 0168; 0169; 0170; 0194; 0195; 0196; 0409; 0410; 0411; 0436; 0437; 0438; 0474; 0475; 0476; 0477; 0478 ASTH-0007; 0008; 0009; 0010; 0011; 0012; 0092; 0093; 0094; 0095; 0096; 0120; 0121; 0122; 0123; 0124; 0125; 0126; 0142; 0143; 0144; 0145; 0146; 0147; 0148; 0169; 0170; 0171; 0172; 0173; 0174; 0175; 0187; 0188; 0189; 0190; 0191; 0192; 0269; 0270; 0271; 0272; 0273; 0293; 0294; 0295; 0296; 0306; 0307; 0308; 0309; 0310; 0311; 0324; 0325; 0326; 0327; 0330; 0331; 0332; 0333; 0334; 0335; 0336; 0337; 0338; 0339; 0358; 0359; 0360; 0361; 0362; 0363; 0364; 0365; 0383; 0384; 0385; 0386; 0387; 0388; 0389; 0390; 0450; 0476; 0477; 0478; 0479; 0480; 0481; 0488; 0489; 0490; 0491  Serial Numbers Distributed OUS: ASTA-0253; 0289; 0290; 0327; 0362; 0404; 0405; 0426; 0427; 0428; 0429; 0430 ASTB-0003; 0005; 0007; 0028; 0029; 0030; 0031; 0032; 0033; 0075; 0076; 0077; 0079; 0080; 0081; 0082; 0083; 0084; 0134; 0195; 0206; 0219; 0220; 0237 ASTC-0001; 0002; 0003; 0004; 0026; 0138; 0163; 0180; 0181; 0194;  ASTD-0015; 0016; 0050; 0061; 0062; 0063; 0064; 0065; 0066; 0203; 0204; 0205; 0265; 0266; 0267 ASTE-0034; 0035; 0057; 0058; 0059; 0060; 0062; 0085; 0108; 0127; 0128; 0175; 0202; 0223; 0224; 0300; 0325; 0326; 0327; 0328; 0329; 0353; 0354; 0355; 0356 ASTF-0051; 0052; 0053; 0054; 0112; 0113; 0435; 0471 ASTH-0039; 0040; 0045; 0046; 0081; 0082; 0176; 0193; 0194; 0204; 0217; 0218; 0219; 0225; 0226; 0243; 0244; 0245; 0246; 0255; 0256; 0382; 0403; 0404; 0405; 0406; 0434; 0435; 0436; 0437; 0451; 0452; 0453; 0 ASTJ-0063; 0064; 0065; 0066; 0067; 0068; 0089; 0090; 0091; 0092; 0145; 0146; 0147; 0171; 0237 ASTK-0002. A RECORDED FDA enforcement action (occurred=true).",
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        "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-0305-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0305-2025&lang=eng"
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      "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."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0305-2025/fda-classification",
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      "name": "FDA classified recall Z-0305-2025 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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.",
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      "reviewStatus": "current",
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      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "value": "Class I",
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          "name": "U.S. FDA recall classification (openFDA enforcement)",
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      },
      "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-0305-2025/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",
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      "epistemicStatus": {
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        "supported": true,
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        "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-0305-2025",
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            "Field": "Recall number",
            "Value": "Z-0305-2025",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
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            "Status": "determination"
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            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Draeger Medical, Inc.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.",
            "Status": "recorded"
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        {
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          "item": {
            "Field": "Initiated",
            "Value": "2024-10-15",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Model/Catalog Number: 8621600; UDI-DI Number: 04048675556183; Serial Numbers Distributed in the US: ASTA-0307; 0309; 0311; 0349; 0350; 0351; 0353; 0363; 0365; 0394; 0408; 0409 ASTB-0048; 0286; 0287; 0288; 0289; 0290; 0291; 0304; 0305; 0306; 0307; 0308; 0309; 0317; 0318; 0319; 0320; 0321; 0322 ASTC-0006; 0007; 0068; 0069; 0070; 0082; 0083; 0099; 0100; 0101; 0105; 0106; 0107; 0108; 0109; 0118; 0119; 0136; 0137; 0229; 0230; 0243; 0244; 0245 ASTD-0008; 0009; 0010; 0011; 0012; 0013; 0014; 0129; 0130; 0131; 0132; 0133; 0134; 0135; 0154; 0159; 0160; 0161; 0162; 0163; 0164; 0165; 0166; 0167; 0168; 0169; 0181; 0182; 0183; 0193; 0194; 0195; 0225; 0226; 0227; 0228; 0229; 0230; 0231; 0238; 0239; 0240; 0241; 0242; 0243; 0244; 0245 ASTE-0016; 0017; 0077; 0078; 0079; 0086; 0087; 0122; 0123; 0124; 0125; 0126; 0129; 0130; 0131; 0163; 0164; 0165; 0166; 0171; 0172; 0173; 0174; 0195; 0196; 0197; 0198; 0203; 0225; 0226; 0246; 0247; 0248; 0249; 0250; 0278; 0279; 0280; 0281; 0301; 0302; 0303; 0304; 0305; 0306; 0348; 0349; 0350; 0351; 0352; 0357; 0358; 0359; 0360; 0361; 0362 ASTF-0001; 0002; 0003; 0004; 0014; 0015; 0016; 0017; 0018; 0030; 0031; 0032; 0033; 0034; 0035; 0036; 0037; 0055; 0061; 0062; 0063; 0070; 0071; 0076; 0077; 0078; 0079; 0080; 0081; 0121; 0122; 0123; 0124; 0125; 0135; 0136; 0137; 0138; 0139; 0140; 0141; 0168; 0169; 0170; 0194; 0195; 0196; 0409; 0410; 0411; 0436; 0437; 0438; 0474; 0475; 0476; 0477; 0478 ASTH-0007; 0008; 0009; 0010; 0011; 0012; 0092; 0093; 0094; 0095; 0096; 0120; 0121; 0122; 0123; 0124; 0125; 0126; 0142; 0143; 0144; 0145; 0146; 0147; 0148; 0169; 0170; 0171; 0172; 0173; 0174; 0175; 0187; 0188; 0189; 0190; 0191; 0192; 0269; 0270; 0271; 0272; 0273; 0293; 0294; 0295; 0296; 0306; 0307; 0308; 0309; 0310; 0311; 0324; 0325; 0326; 0327; 0330; 0331; 0332; 0333; 0334; 0335; 0336; 0337; 0338; 0339; 0358; 0359; 0360; 0361; 0362; 0363; 0364; 0365; 0383; 0384; 0385; 0386; 0387; 0388; 0389; 0390; 0450; 0476; 0477; 0478; 0479; 0480; 0481; 0488; 0489; 0490; 0491  Serial Numbers Distributed OUS: ASTA-0253; 0289; 0290; 0327; 0362; 0404; 0405; 0426; 0427; 0428; 0429; 0430 ASTB-0003; 0005; 0007; 0028; 0029; 0030; 0031; 0032; 0033; 0075; 0076; 0077; 0079; 0080; 0081; 0082; 0083; 0084; 0134; 0195; 0206; 0219; 0220; 0237 ASTC-0001; 0002; 0003; 0004; 0026; 0138; 0163; 0180; 0181; 0194;  ASTD-0015; 0016; 0050; 0061; 0062; 0063; 0064; 0065; 0066; 0203; 0204; 0205; 0265; 0266; 0267 ASTE-0034; 0035; 0057; 0058; 0059; 0060; 0062; 0085; 0108; 0127; 0128; 0175; 0202; 0223; 0224; 0300; 0325; 0326; 0327; 0328; 0329; 0353; 0354; 0355; 0356 ASTF-0051; 0052; 0053; 0054; 0112; 0113; 0435; 0471 ASTH-0039; 0040; 0045; 0046; 0081; 0082; 0176; 0193; 0194; 0204; 0217; 0218; 0219; 0225; 0226; 0243; 0244; 0245; 0246; 0255; 0256; 0382; 0403; 0404; 0405; 0406; 0434; 0435; 0436; 0437; 0451; 0452; 0453; 0 ASTJ-0063; 0064; 0065; 0066; 0067; 0068; 0089; 0090; 0091; 0092; 0145; 0146; 0147; 0171; 0237 ASTK-0002",
            "Status": "recorded"
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution in the states of AL, AZ, CA, FL, GA, IA, IL, KY, MA, ME, ND, NE, NH, NJ, NY, OH, PA, TN, TX, WI, WY.  International distribution: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Columbia, Croatia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Malaysia, Mauritius, Mexico, Morocco, Namibia, Nepal, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Vietnam.",
            "Status": "recorded"
          }
        }
      ]
    }
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