GE Healthcare recalls Carestation 620 SE anesthesia systems with model 1012-9620-012 that may fail to provide effective ventilation in Volume Control Ventilation mode, risking inadequate patient breathing 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 Carestation 620 SE anesthesia systems that may not properly ventilate patients in Volume Control Ventilation mode. This could lead to inadequate breathing during surgery if the system fails to function correctly.
The anesthesia delivery system may not provide effective ventilation when set to Volume Control Ventilation (VCV) mode. This means patients could receive insufficient oxygen during surgery if the system fails to function properly in this mode. The system can still work safely in Pressure Control Ventilation (PCV) or PCV-VG modes, or with manual ventilation.
Healthcare providers using the recalled Carestation 620 SE anesthesia systems with model number 1012-9620-012 are most at risk. Patients undergoing surgery with these systems could experience breathing difficulties if the ventilation fails.
Check for the model number 1012-9620-012 on the Carestation 620 SE anesthesia system. The serial numbers listed in the recall include SM624250018WC through SM624330023WC.
Verify the model number on your Carestation 620 SE anesthesia system. The affected model is 1012-9620-012.
If using Volume Control Ventilation mode, switch to Pressure Control Ventilation (PCV) or PCV-VG mode, or manual ventilation, to ensure effective patient breathing.
The anesthesia delivery system may not provide effective ventilation in Volume Control Ventilation (VCV) mode, which could lead to inadequate patient breathing during surgery.
The affected model number is 1012-9620-012 for the Carestation 620 SE anesthesia system.
Check the model number on your Carestation 620 SE anesthesia system. The affected model is 1012-9620-012 with serial numbers listed in the recall.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1626-2025 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1626-2025 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.
