GE Healthcare recalls Carestation 620/650/650c A2 anesthesia systems due to potential loose cable connections causing loss of mechanical ventilation. Affected units may require immediate attention to prevent hypoxia.
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 specific models of anesthesia machines (Carestation 620/650/650c A2) because a loose cable connection could cause loss of mechanical ventilation. If a clinician doesn't intervene, this could lead to hypoxia (oxygen deprivation) in patients.
A loose cable connection inside the anesthesia device can cause the system to lose mechanical ventilation. This means the machine stops delivering oxygen to patients, and the system will trigger high-priority audio and visual alarms. If the clinician doesn't act quickly, patients could become hypoxic (oxygen-deprived).
Healthcare facilities using the affected anesthesia machines, particularly those in hospitals or clinics where patients receive general anesthesia. Patients under anesthesia are at risk if the machine malfunctions.
Check for the Carestation 620 A2 (model 1012-9620-002), Carestation 650 A2 (model 1012-9650-002), or Carestation 650c A2 (model 1012-9655-002) with specific serial numbers listed in the recall notice. These units were manufactured with certain lot/serial numbers.
Inspect the device for any loose cables inside the anesthesia system. If found, stop using the device immediately.
Reach out to GE Healthcare for guidance on next steps or to confirm if your device is affected.
GE Healthcare has identified a potential loose cable connection in specific anesthesia devices that could cause loss of mechanical ventilation, leading to hypoxia if not addressed.
Check if your device matches the model and serial numbers listed in the recall notice. If it does, inspect for loose cables and contact GE Healthcare for further instructions.
The recall states that loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene. This is a serious risk but the remedy does not specify immediate stop-use; it requires checking for loose cables and contacting GE Healthcare.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0814-2020 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0814-2020 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.
