GE Healthcare recalls Carestation 650 A2 anesthesia systems with model 1012-9650-002 that may not provide effective ventilation in Volume Control Ventilation mode. Affected units can be identified by serial numbers listed in the recall notice.
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 their Carestation 650 A2 anesthesia systems because they may not provide effective ventilation in Volume Control Ventilation (VCV) mode. This could lead to inadequate breathing support during surgery. The issue affects certain units with model number 1012-9650-002.
The anesthesia system may fail to provide effective ventilation when set to Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can still be achieved using Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes, or manual ventilation. This risk could lead to inadequate breathing support during surgery if the system fails to maintain proper ventilation.
Healthcare providers using the Carestation 650 A2 anesthesia systems with model number 1012-9650-002 are most at risk. This recall applies to units sold in the U.S. and Canada.
Check if your Carestation 650 A2 anesthesia system has model number 1012-9650-002. Affected units have serial numbers listed in the recall notice, including SM723010002WB through SM724520311WB.
Verify your anesthesia system's model number is 1012-9650-002.
Reach out to GE Healthcare for guidance on next steps if your unit is affected.
The affected model number is 1012-9650-002.
Check if your unit has model number 1012-9650-002 and a serial number listed in the recall notice (e.g., SM723010002WB through SM724520311WB).
Contact GE Healthcare for guidance on next steps if your unit is affected.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1629-2025 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1629-2025 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.