GE Healthcare recalls specific anesthesia systems that may not provide effective ventilation in Volume Control Ventilation mode, risking inadequate breathing support 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 certain Carestation 650c A1 anesthesia systems that may not provide effective ventilation in Volume Control Ventilation (VCV) mode. This could lead to inadequate breathing support for patients during surgery if the system fails to function correctly.
The anesthesia delivery system may not provide effective ventilation when set to Volume Control Ventilation mode. This means patients could receive insufficient oxygen during surgery if the system malfunctions, potentially leading to breathing difficulties or inadequate anesthesia delivery.
Healthcare providers using the specific model and serial numbers listed in the recall notice are most at risk. Patients undergoing anesthesia with these systems could experience breathing difficulties if the device fails to ventilate properly.
Check for the model number 1012-9655-200 on the Carestation 650c A1 anesthesia system. The specific serial numbers listed in the recall notice include SM824450008WD through SM825020006MD.
Verify the model number on your anesthesia system to see if it matches the recalled model 1012-9655-200.
Reach out to GE Healthcare for guidance on the next steps if your device is affected by this recall.
The anesthesia system may not provide effective ventilation in Volume Control Ventilation mode, which could lead to inadequate breathing support for patients during surgery.
Check the model number and serial numbers listed in the recall notice. Contact GE Healthcare for further instructions if your device is affected.
The recall states that the system may not provide effective ventilation in VCV mode, which could lead to breathing difficulties during surgery. However, the remedy is not specified, so users should contact GE Healthcare for guidance.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1634-2025 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1634-2025 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.
