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  "name": "GE Healthcare Carestation anesthesia system, product number and REF numbers:    Carestation 610 A1, REF 1012-9620-222;   Carestation 620 A1  REF 1012-9620-000;   Carestation 620 A1, REF 1012-9620-200;   Carestation 620 A1, REF 1012-9620-202;   Carestation 620 SE A1, REF 1012-9620-212;   Carestation 630 A1, REF 1012-9650-222;   Carestation 650 A1, REF 1012-9650-000;   Carestation 650 A1, REF 1012-9650-200;   Carestation 650 A1, REF 1012-9650-202;   Carestation 650 SE A1, REF 1012-9650-212;   Carestation 650c A1, REF 1012-9655-202; Anesthesia Gas Machine    Products for which affected PMB can be used as a spare part:    Carestation 620 A2, REF 1012-9620-002 00840682124546  Carestation 620 SE A2, REF 1012-9620-012 00195278569677  Carestation 650 A2, REF 1012-9650-002 00840682124560  Carestation 650 SE A2, REF 1012-9650-012 00195278569684  Carestation 650c A1, REF 1012-9655-000 00840682103954  Carestation 650c A2, REF 1012-9655-002 00840682124539  Carestation 650c A1, REF 1012-9655-200 00195278439543",
  "description": "FDA recall Z-0913-2026 — GE Medical Systems China Co., Ltd. is recalling GE Healthcare Carestation anesthesia system, product number and REF numbers:    Carestation 610 A1, REF 1012-9620-222;   Carestation 620 A1  REF 1012-9620-000;   Carestation 620 A1, REF 1012-9620-200;   Carestation 620 A1, REF 1012-9620-202;   Carestation 620 SE A1, REF 1012-9620-212;   Carestation 630 A1, REF 1012-9650-222;   Carestation 650 A1, REF 1012-9650-000;   Carestation 650 A1, REF 1012-9650-200;   Carestation 650 A1, REF 1012-9650-202;   Carestation 650 SE A1, REF 1012-9650-212;   Carestation 650c A1, REF 1012-9655-202; Anesthesia Gas Machine    Products for which affected PMB can be used as a spare part:    Carestation 620 A2, REF 1012-9620-002 00840682124546  Carestation 620 SE A2, REF 1012-9620-012 00195278569677  Carestation 650 A2, REF 1012-9650-002 00840682124560  Carestation 650 SE A2, REF 1012-9650-012 00195278569684  Carestation 650c A1, REF 1012-9655-000 00840682103954  Carestation 650c A2, REF 1012-9655-002 00840682124539  Carestation 650c A1, REF 1012-9655-200 00195278439543 (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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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "@type": "schema:MedicalDevice",
    "name": "GE Healthcare Carestation anesthesia system, product number and REF numbers:    Carestation 610 A1, REF 1012-9620-222;   Carestation 620 A1  REF 1012-9620-000;   Carestation 620 A1, REF 1012-9620-200;   Carestation 620 A1, REF 1012-9620-202;   Carestation 620 SE A1, REF 1012-9620-212;   Carestation 630 A1, REF 1012-9650-222;   Carestation 650 A1, REF 1012-9650-000;   Carestation 650 A1, REF 1012-9650-200;   Carestation 650 A1, REF 1012-9650-202;   Carestation 650 SE A1, REF 1012-9650-212;   Carestation 650c A1, REF 1012-9655-202; Anesthesia Gas Machine    Products for which affected PMB can be used as a spare part:    Carestation 620 A2, REF 1012-9620-002 00840682124546  Carestation 620 SE A2, REF 1012-9620-012 00195278569677  Carestation 650 A2, REF 1012-9650-002 00840682124560  Carestation 650 SE A2, REF 1012-9650-012 00195278569684  Carestation 650c A1, REF 1012-9655-000 00840682103954  Carestation 650c A2, REF 1012-9655-002 00840682124539  Carestation 650c A1, REF 1012-9655-200 00195278439543",
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      "name": "GE Medical Systems China Co., Ltd."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0913-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0913-2026: GE Medical Systems China Co., Ltd. is recalling GE Healthcare Carestation anesthesia system, product number and REF numbers:    Carestation 610 A1, REF 1012-9620-222;   Carestation 620 A1  REF 1012-9620-000;   Carestation 620 A1, REF 1012-9620-200;   Carestation 620 A1, REF 1012-9620-202;   Carestation 620 SE A1, REF 1012-9620-212;   Carestation 630 A1, REF 1012-9650-222;   Carestation 650 A1, REF 1012-9650-000;   Carestation 650 A1, REF 1012-9650-200;   Carestation 650 A1, REF 1012-9650-202;   Carestation 650 SE A1, REF 1012-9650-212;   Carestation 650c A1, REF 1012-9655-202; Anesthesia Gas Machine    Products for which affected PMB can be used as a spare part:    Carestation 620 A2, REF 1012-9620-002 00840682124546  Carestation 620 SE A2, REF 1012-9620-012 00195278569677  Carestation 650 A2, REF 1012-9650-002 00840682124560  Carestation 650 SE A2, REF 1012-9650-012 00195278569684  Carestation 650c A1, REF 1012-9655-000 00840682103954  Carestation 650c A2, REF 1012-9655-002 00840682124539  Carestation 650c A1, REF 1012-9655-200 00195278439543",
      "text": "The FDA logged enforcement record Z-0913-2026: GE Medical Systems China Co., Ltd. is voluntarily recalling GE Healthcare Carestation anesthesia system, product number and REF numbers:    Carestation 610 A1, REF 1012-9620-222;   Carestation 620 A1  REF 1012-9620-000;   Carestation 620 A1, REF 1012-9620-200;   Carestation 620 A1, REF 1012-9620-202;   Carestation 620 SE A1, REF 1012-9620-212;   Carestation 630 A1, REF 1012-9650-222;   Carestation 650 A1, REF 1012-9650-000;   Carestation 650 A1, REF 1012-9650-200;   Carestation 650 A1, REF 1012-9650-202;   Carestation 650 SE A1, REF 1012-9650-212;   Carestation 650c A1, REF 1012-9655-202; Anesthesia Gas Machine    Products for which affected PMB can be used as a spare part:    Carestation 620 A2, REF 1012-9620-002 00840682124546  Carestation 620 SE A2, REF 1012-9620-012 00195278569677  Carestation 650 A2, REF 1012-9650-002 00840682124560  Carestation 650 SE A2, REF 1012-9650-012 00195278569684  Carestation 650c A1, REF 1012-9655-000 00840682103954  Carestation 650c A2, REF 1012-9655-002 00840682124539  Carestation 650c A1, REF 1012-9655-200 00195278439543 — reason: Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure.    Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur.   Following the reboot, the system will not return to the previous ventilation settings.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-11-14. Affected lots/codes: REF 1012-9620-222:  GTIN 00195278626301;  REF 1012-9620-000:  GTIN 00840682103985;  REF 1012-9620-200:  GTIN 00195278439536;  REF 1012-9620-202:  GTIN 00195278626158;  REF 1012-9620-212:  GTIN 00195278626561;  REF 1012-9650-222:  GTIN 00195278626592;  REF 1012-9650-000:  GTIN 00840682103947;  REF 1012-9650-200:  GTIN 00195278439529;  REF 1012-9650-202:  GTIN 00195278626585;  REF 1012-9650-212:  GTIN 00195278625687;  REF 1012-9655-202:  GTIN 00195278625953;  REF 1012-9620-002:  GTIN  00840682124546;  REF 1012-9620-012:  GTIN 00195278569677;  REF 1012-9650-002:  GTIN 00840682124560;   REF 1012-9650-012:  GTIN 00195278569684;  REF 1012-9655-000:  GTIN 00840682103954;  REF 1012-9655-002:  GTIN 00840682124539;   REF 1012-9655-200:  GTIN 00195278439543.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
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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-0913-2026&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "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-0913-2026&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0913-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0913-2026 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
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        "value": "Class I",
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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-0913-2026/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",
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      "epistemicStatus": {
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      "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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            "Value": "Z-0913-2026",
            "Status": "recorded"
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            "Value": "Devices",
            "Status": "recorded"
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            "Field": "Classification",
            "Value": "Class I",
            "Status": "determination"
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Field": "Recalling firm",
            "Value": "GE Medical Systems China Co., Ltd.",
            "Status": "recorded"
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            "Field": "Reason",
            "Value": "Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure.    Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur.   Following the reboot, the system will not return to the previous ventilation settings.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2025-11-14",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "REF 1012-9620-222:  GTIN 00195278626301;  REF 1012-9620-000:  GTIN 00840682103985;  REF 1012-9620-200:  GTIN 00195278439536;  REF 1012-9620-202:  GTIN 00195278626158;  REF 1012-9620-212:  GTIN 00195278626561;  REF 1012-9650-222:  GTIN 00195278626592;  REF 1012-9650-000:  GTIN 00840682103947;  REF 1012-9650-200:  GTIN 00195278439529;  REF 1012-9650-202:  GTIN 00195278626585;  REF 1012-9650-212:  GTIN 00195278625687;  REF 1012-9655-202:  GTIN 00195278625953;  REF 1012-9620-002:  GTIN  00840682124546;  REF 1012-9620-012:  GTIN 00195278569677;  REF 1012-9650-002:  GTIN 00840682124560;   REF 1012-9650-012:  GTIN 00195278569684;  REF 1012-9655-000:  GTIN 00840682103954;  REF 1012-9655-002:  GTIN 00840682124539;   REF 1012-9655-200:  GTIN 00195278439543.",
            "Status": "recorded"
          }
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Argentina, Australia, Bahamas, Bangladesh, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada, China, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Guatemala, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Latvia, Lithuania, Malaysia, Mexico, Moldova, Morocco, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Thailand, Tunisia, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela and Vietnam.",
            "Status": "recorded"
          }
        }
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