GE Medical Systems China Co., Ltd. recalls non-US distributed GE Carestation 620/650/650c anesthesia systems with specific serial numbers due to potential gas switch malfunction that could lead to hypoxia. Affected units include models A1 and A2.
On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air function the switch could unexpectedly switch from the Aux O2 + Air position back to the circle position. These situations could lead to hypoxia.
GE Medical Systems China Co., Ltd. is recalling non-US distributed GE Carestation 620/650/650c anesthesia systems with specific serial numbers. The recall is due to a potential issue where the gas switch could unexpectedly switch positions, leading to hypoxia (low oxygen levels).
The system's gas switch may unexpectedly switch from the Auxiliary Common Gas Outlet (ACGO) position back to the circle position, or from Aux O2 + Air position back to circle position. This could cause hypoxia (low oxygen levels) in patients during anesthesia procedures.
Healthcare professionals using these anesthesia systems in non-US facilities are most at risk. The affected units have specific serial numbers listed in the recall notice.
Check if your GE Carestation 620/650/650c anesthesia system has the specific serial numbers listed in the recall notice. The recall applies to non-US distributed units.
Review the list of affected serial numbers provided in the recall notice to determine if your unit is included.
Reach out to GE Medical Systems China Co., Ltd. for guidance on next steps if your unit is affected.
The gas switch may unexpectedly switch from the Auxiliary Common Gas Outlet (ACGO) position back to the circle position, or from Aux O2 + Air position back to circle position, potentially causing hypoxia.
No, this recall applies only to non-US distributed GE Carestation 620/650/650c anesthesia systems.
Compare your unit's serial number with the list of affected serial numbers provided in the recall notice.
We’ve drafted a message you can send GE Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2954-2018 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-2954-2018 from GE Medical Systems. 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.
