GE Healthcare recalls Carestation 620 A1 anesthesia systems with model 1012-9620-200 that may fail to provide effective ventilation in Volume Control Ventilation mode, requiring immediate action.
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 systems that may not work properly during Volume Control Ventilation mode. This could lead to inadequate breathing support for patients during surgery.
These anesthesia systems may fail to provide effective ventilation when set to Volume Control Ventilation (VCV) mode. Patients could receive insufficient oxygen or experience breathing difficulties if the system is used in this mode.
Healthcare providers using the Carestation 620 A1 anesthesia systems with model number 1012-9620-200 are most at risk. Patients undergoing surgery with these systems could experience breathing issues.
Check for the model number 1012-9620-200 on the Carestation 620 A1 anesthesia system. The serial numbers listed in the recall include a range of specific codes starting with SM or SM62.
Ensure the anesthesia system is not set to Volume Control Ventilation (VCV) mode when in use.
Switch to Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes for effective ventilation.
Reach out to GE Healthcare for further assistance with the recall.
The affected model is 1012-9620-200. Serial numbers include a range starting with SM or SM62.
Yes, the system may fail to provide effective ventilation in Volume Control Ventilation mode, which could lead to breathing difficulties for patients.
Ensure the system is not in Volume Control Ventilation mode and switch to Pressure Control Ventilation or Pressure Control Ventilation Volume Guarantee 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-1627-2025 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1627-2025 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.
