GE Healthcare recalls specific CARESTATION 650C A2 anesthesia systems (model 1012-9655-002) due to potential ventilation failure in Volume Control Ventilation mode. Affected units may require alternative ventilation methods to ensure patient safety.
Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
GE Healthcare is recalling certain CARESTATION 650C A2 anesthesia systems because they may not provide effective ventilation in Volume Control Ventilation mode. This could lead to inadequate patient breathing during surgery if the system fails to function properly.
The anesthesia system may not provide effective ventilation when set to Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can only be achieved through Pressure Control Ventilation (PCV) or Manual ventilation methods, which may not be practical during surgery.
Healthcare providers using the specific model of anesthesia system are affected. Patients undergoing surgery with this equipment could be at risk if the ventilation system fails.
Check for the model number 1012-9655-002 on the anesthesia system. Affected units have serial numbers starting with SM823250002WB or similar listed in the recall notice.
Ensure the anesthesia system is not set to Volume Control Ventilation (VCV) mode when using it for patient ventilation.
If the system is in VCV mode, switch to Pressure Control Ventilation (PCV) or Manual ventilation to maintain effective patient ventilation.
The anesthesia system may not provide effective ventilation in Volume Control Ventilation (VCV) mode, which could lead to inadequate patient breathing during surgery.
The affected model is the GE Healthcare CARESTATION 650C A2 with model/REF number 1012-9655-002.
Check for the model number 1012-9655-002 and serial numbers listed in the recall notice, such as SM823250002WB.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1633-2025 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1633-2025 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.
