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  "name": "Software version 5.3 in:   RAPIDPoint 500e Blood Gas System (USA)  Siemens Material Number:  11416751    RAPIDPoint 500e Blood Gas System (China) 11416752;  RAPIDPoint 500e Blood Gas System (Japan) 11416754;  RAPIDPoint 500e Blood Gas System (ROW) 11416755 ;",
  "description": "FDA recall Z-2214-2024 — Siemens Healthcare Diagnostics Inc is recalling Software version 5.3 in:   RAPIDPoint 500e Blood Gas System (USA)  Siemens Material Number:  11416751    RAPIDPoint 500e Blood Gas System (China) 11416752;  RAPIDPoint 500e Blood Gas System (Japan) 11416754;  RAPIDPoint 500e Blood Gas System (ROW) 11416755 ; (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/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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    "name": "Software version 5.3 in:   RAPIDPoint 500e Blood Gas System (USA)  Siemens Material Number:  11416751    RAPIDPoint 500e Blood Gas System (China) 11416752;  RAPIDPoint 500e Blood Gas System (Japan) 11416754;  RAPIDPoint 500e Blood Gas System (ROW) 11416755 ;",
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      "name": "Siemens Healthcare Diagnostics Inc"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2214-2024/enforcement-record",
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      "name": "FDA recall Z-2214-2024: Siemens Healthcare Diagnostics Inc is recalling Software version 5.3 in:   RAPIDPoint 500e Blood Gas System (USA)  Siemens Material Number:  11416751    RAPIDPoint 500e Blood Gas System (China) 11416752;  RAPIDPoint 500e Blood Gas System (Japan) 11416754;  RAPIDPoint 500e Blood Gas System (ROW) 11416755 ;",
      "text": "The FDA logged enforcement record Z-2214-2024: Siemens Healthcare Diagnostics Inc is voluntarily recalling Software version 5.3 in:   RAPIDPoint 500e Blood Gas System (USA)  Siemens Material Number:  11416751    RAPIDPoint 500e Blood Gas System (China) 11416752;  RAPIDPoint 500e Blood Gas System (Japan) 11416754;  RAPIDPoint 500e Blood Gas System (ROW) 11416755 ; — reason: Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary mode. With this software version, samples run in the capillary mode are incorrectly labeled as arterial when displayed on the LIS, leading to the potential for results to be flagged according to an established arterial range. Capillary sample results are correctly identified as capillary on both the RAPIDPoint 500e system display and the instrument printouts. The issue only affects the new software version 5.3 and only capillary sample mode is impacted. The inability to distinguish specimen sources for blood gas may lead to incorrect diagnoses and management decisions.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-05-17. Affected lots/codes: UDI-DI: (1)RAPIDPoint 500e Blood Gas System (USA)     00630414286143; (2)RAPIDPoint 500e Blood Gas System (China)  00630414286150; (3) RAPIDPoint 500e Blood Gas System (Japan)  00630414286167; (4) RAPIDPoint 500e Blood Gas System (ROW)  00630414286174  Software Version 5.3.. A RECORDED FDA enforcement action (occurred=true).",
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        "adjudged": 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-2214-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
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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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      "name": "FDA classified recall Z-2214-2024 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.",
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        "value": "Class II",
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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."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2214-2024/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.",
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        "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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            "Value": "Class II",
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            "Value": "Ongoing — the recall is still being carried out.",
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          "item": {
            "Field": "Recalling firm",
            "Value": "Siemens Healthcare Diagnostics Inc",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary mode. With this software version, samples run in the capillary mode are incorrectly labeled as arterial when displayed on the LIS, leading to the potential for results to be flagged according to an established arterial range. Capillary sample results are correctly identified as capillary on both the RAPIDPoint 500e system display and the instrument printouts. The issue only affects the new software version 5.3 and only capillary sample mode is impacted. The inability to distinguish specimen sources for blood gas may lead to incorrect diagnoses and management decisions.",
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            "Value": "2024-05-17",
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            "Value": "UDI-DI: (1)RAPIDPoint 500e Blood Gas System (USA)     00630414286143; (2)RAPIDPoint 500e Blood Gas System (China)  00630414286150; (3) RAPIDPoint 500e Blood Gas System (Japan)  00630414286167; (4) RAPIDPoint 500e Blood Gas System (ROW)  00630414286174  Software Version 5.3.",
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution in the states of FL, GA, LA, MI, NC and the countries of Chile, Costa Rica, France, Germany, Japan, Lebanon, Mexico, Netherlands, New Zealand, Poland, Spain, Turkey, United Kingdom.",
            "Status": "recorded"
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