GE Healthcare recalls Carestation 650 A1 anesthesia systems with model 1012-9650-200 due to potential ventilation failure in Volume Control Ventilation mode. Affected units may not provide effective ventilation, risking 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 specific models of Carestation 650 A1 anesthesia systems because they may not provide effective ventilation in Volume Control Ventilation (VCV) mode. This could lead to inadequate breathing support for patients during anesthesia procedures.
The anesthesia system may fail to provide effective ventilation when set to Volume Control Ventilation (VCV) mode. However, it can still function safely in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes, or with manual ventilation.
Healthcare providers using the Carestation 650 A1 anesthesia systems with model number 1012-9650-200 are most at risk. Patients undergoing anesthesia with these systems could experience inadequate ventilation.
Check for the model number 1012-9650-200 on the Carestation 650 A1 anesthesia system. The serial numbers listed in the recall include many 'SM' and 'SM72' prefixes followed by numbers and 'MD' or 'WD' suffixes.
Verify the model number on your Carestation 650 A1 anesthesia system; affected units have model number 1012-9650-200.
If using the system in VCV mode, switch to PCV or PCV-VG mode, or use manual ventilation to ensure effective ventilation.
The Carestation 650 A1 anesthesia system with model number 1012-9650-200 may not provide effective ventilation in Volume Control Ventilation (VCV) mode, which could lead to inadequate breathing support for patients.
Check for the model number 1012-9650-200 on your Carestation 650 A1 anesthesia system. Affected units have specific serial numbers listed in the recall notice.
If your system is affected, switch to Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, or use manual ventilation to ensure effective ventilation.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1631-2025 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1631-2025 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.
