GE Healthcare recalls Carestation 620 A1 anesthesia systems with serial numbers starting with SM623... due to potential failure to provide effective ventilation in Volume Control Ventilation mode. Affected units may require replacement or repair.
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 620 A1 anesthesia systems that may not provide effective ventilation in Volume Control Ventilation (VCV) mode. This could lead to inadequate breathing support during surgery. The recall applies to specific serial numbers listed in the notice.
The anesthesia systems may not provide effective ventilation when set to 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 through manual ventilation. If the system fails to maintain proper ventilation in VCV mode, it could lead to inadequate breathing support during critical medical procedures.
Healthcare providers using the Carestation 620 A1 anesthesia systems with the listed serial numbers are most at risk. Patients undergoing surgery with these systems could experience breathing issues if the ventilation fails.
Check if your Carestation 620 A1 anesthesia system has a serial number starting with SM623 followed by 10 digits (e.g., SM623390002MA). The recall includes specific serial numbers listed in the official notice.
Verify your Carestation 620 A1's serial number starts with SM623 followed by 10 digits (e.g., SM623390002MA).
Reach out to GE Healthcare for instructions on repair or replacement of affected units.
The anesthesia systems may not provide effective ventilation in Volume Control Ventilation (VCV) mode, which could lead to inadequate breathing support during surgery.
Check if your Carestation 620 A1 has a serial number starting with SM623 followed by 10 digits (e.g., SM623390002MA).
No, but you should contact GE Healthcare to determine if your unit needs repair or replacement.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1624-2025 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1624-2025 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.
