GE Healthcare CARESTATION 750 Anesthesia System Volume Control Ventilation Failure
Certain GE Healthcare CARESTATION 750 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Affected systems can deliver ventilation through alternative modes or manual ventilation.
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: This is an FDA Class I recall of a critical medical device (anesthesia system) that directly affects patient ventilation during surgery. Although no illnesses or injuries are explicitly reported in the source, the potential for harm is significant because the device is used in the operating room where ventilation failure could pose serious risk to patients. Per the rubric, FDA Class I recalls are never scored below 4, and the severity label matches the score.
Plain-English summary
GE Healthcare CARESTATION 750 A1 anesthesia delivery systems (Model/REF 1012-9750-000) are subject to a recall due to a ventilation failure. Certain units will not provide effective ventilation when operating in Volume Control Ventilation (VCV) mode.
The affected systems can achieve effective ventilation through alternative operating modes: Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG), as well as through manual ventilation. Approximately 4,339 units have been distributed worldwide, including to the United States, Puerto Rico, and numerous international locations.
Patients and healthcare providers using affected systems should switch to PCV, PCV-VG, or manual ventilation modes rather than VCV mode. Users should contact GE Healthcare or their service representative for further guidance, or visit the FDA recall notice at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-1635-2025.
The recalled product
- Product
- GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system.
- Manufacturer
- GE Medical Systems China Co., Ltd.
- Hazard
- ventilation-failure
- device-malfunction
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 00840682145596
- Serial Numbers: SQS24500010MA
- SQS24500011MA
- SQS24500012MA
- SQS24500013MA
- SQS24500014MA
- SQS24500015MA
- SQS24500016MA
- SQS24500017MA
- SQS24130011MA
- SQS24130012MA
- SQS24130013MA
- SQS24130014MA
- SQS24130015MA
- SQS24130016MA
- SQS24130017MA
- SQS24130018MA
- SQS24170062MA
- SQS24170063MA
- SQS24170064MA
Distribution
Distributed nationwide across the United States.
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