GE Healthcare recalls Carestation 650C A1 anesthesia systems with model 1012-9655-000 due to potential ventilation failure in Volume Control Ventilation mode. Affected units may not provide effective ventilation during surgery.
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 specific models of anesthesia machines (Carestation 650C A1) that may not provide effective ventilation in Volume Control Ventilation mode. This could lead to inadequate breathing during surgery if the system fails to function properly.
The anesthesia delivery system may not provide effective ventilation when set to Volume Control Ventilation (VCV) mode. This could result in insufficient oxygen delivery to patients during surgery. The system functions correctly in Pressure Control Ventilation (PCV) or PCV-VG modes, or with manual ventilation.
Healthcare providers using the Carestation 650C A1 anesthesia systems with model number 1012-9655-000 are affected. Patients undergoing surgery with these systems face the risk of inadequate ventilation.
Check for the model number 1012-9655-000 on the Carestation 650C A1 anesthesia system. Serial numbers listed in the recall include SM823080001MA through SM824440013MA.
Verify if your anesthesia system is set to Volume Control Ventilation (VCV) mode before use.
If in VCV mode, switch to Pressure Control Ventilation (PCV) or PCV-VG mode, or use manual ventilation.
The anesthesia delivery system may not provide effective ventilation in Volume Control Ventilation (VCV) mode, which could lead to inadequate breathing during surgery.
The affected model is the Carestation 650C A1 with model number 1012-9655-000. Serial numbers include SM823080001MA through SM824440013MA.
Yes, but only if you switch to Pressure Control Ventilation (PCV) or PCV-VG mode, or use manual ventilation instead of VCV mode.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1632-2025 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1632-2025 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.
