GE Healthcare recalls Carestation 620/650/650c A1 anesthesia systems due to potential loose cable connections that could cause loss of mechanical ventilation. This may lead to hypoxia if not addressed.
GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene.
GE Healthcare is recalling Carestation 620/650/650c A1 anesthesia systems because a loose cable connection inside some units could cause loss of mechanical ventilation. This might lead to hypoxia (lack of oxygen) if the clinician doesn't intervene.
A loose cable connection inside the anesthesia device can cause the system to lose mechanical ventilation. This means the device might stop providing breathing support to patients. The system will then trigger high-priority audio and visual alarms, but if the clinician doesn't act quickly, patients could become hypoxic (lack of oxygen).
Healthcare providers using the Carestation 620/650/650c A1 anesthesia systems for patient ventilation are most at risk. The issue affects specific units with certain model numbers.
Check if your Carestation 620/650/650c A1 has a model number starting with 1012-9620-000 or other specific model numbers listed in the recall (e.g., SM619130003MA, SM619020010WA).
Inspect the device for any loose cables or connections inside the anesthesia system.
If the system emits high-priority audio and visual alarms, stop using the device immediately.
The recall includes Carestation 620/650/650c A1 units with model numbers starting with SM619130003MA, SM619020010WA, and other specific model numbers listed in the record.
A loose cable connection can cause loss of mechanical ventilation, which may lead to hypoxia (lack of oxygen) if the clinician does not intervene quickly.
The recall does not specify a fix; users should check for loose cables and stop using the device if alarms trigger.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0813-2020 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0813-2020 from GE Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
