GE Healthcare CARESTATION Anesthesia Systems Ventilation Mode Failure Recall
Certain GE Healthcare CARESTATION 750 A2 anesthesia systems may not provide effective ventilation in Volume Control Ventilation mode. Users should switch to Pressure Control Ventilation or Manual ventilation modes.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall of a medical device used in critical anesthesia delivery. Although no illnesses or injuries are reported in the source text, the failure of primary ventilation mode in an anesthesia system meets the Severe criterion for a structural/functional device defect that could result in serious patient harm.
Plain-English summary
GE Medical Systems China Co., Ltd. is recalling certain GE Healthcare CARESTATION 750 A2 anesthesia delivery systems (Model/REF 1012-9750-002). These systems will not provide effective ventilation when operating in Volume Control Ventilation (VCV) mode.
Affected units may be unable to deliver adequate ventilation in VCV mode, which could pose a risk during anesthesia delivery if the operator does not recognize the issue and switch to an alternative mode.
Effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes, or with Manual ventilation. Operators of affected systems should use these alternative ventilation modes until the equipment is serviced or replaced.
The affected systems were distributed worldwide, including throughout the United States and Puerto Rico. Affected serial numbers are listed on the FDA's recall notice at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-1636-2025.
The recalled product
- Product
- GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system.
- Manufacturer
- GE Medical Systems China Co., Ltd.
- Hazard
- ventilation-failure
- anesthesia-system-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 00840682146470
- Serial Numbers: SQS23480001WB
- SQS23480002WB
- SQS23480003WB
- SQS23480004WB
- SQS23480005WB
- SQS23500002WB
- SQS24510072WB
- SQS24510073WB
- SQS24510074WB
- SQS24510075WB
- SQS24510076WB
- SQS24250017WB
- SQS24250018WB
- SQS24250019WB
- SQS24370029WB
- SQS24370030WB
- SQS24370031WB
- SQS23510004WB
- SQS23370007WB
Distribution
Distributed nationwide across the United States.
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