GE Healthcare recalls Carestation 650 SE anesthesia systems with model 1012-9650-012 due to potential ventilation failure in Volume Control Ventilation mode. Affected units may require repair or replacement.
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 650 SE anesthesia systems that may not provide effective ventilation in Volume Control Ventilation mode. This could lead to inadequate breathing support during medical procedures if the system fails to function properly.
The anesthesia delivery system may not provide effective ventilation when set to Volume Control Ventilation mode. This could result in inadequate breathing support during medical procedures. The system functions properly in Pressure Control Ventilation or Manual ventilation modes.
Healthcare providers using the Carestation 650 SE anesthesia system with model number 1012-9650-012 are most at risk. Patients undergoing anesthesia procedures could be affected if the system fails to maintain proper ventilation.
Check for the model number 1012-9650-012 on the Carestation 650 SE anesthesia system. The product was sold with GTIN 00195278569684 and serial numbers starting with SM724370002WC.
Ensure the anesthesia system is not set to Volume Control Ventilation mode before use.
Reach out to GE Healthcare for repair or replacement options for affected units.
The anesthesia delivery system may not provide effective ventilation in Volume Control Ventilation mode, which could lead to inadequate breathing support during medical procedures.
Model/REF Number 1012-9650-012 for the Carestation 650 SE anesthesia system.
Check for the model number 1012-9650-012 on the Carestation 650 SE anesthesia system. The product was sold with GTIN 00195278569684 and serial numbers starting with SM724370002WC.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1630-2025 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1630-2025 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.
