GE Healthcare Anesthesia Systems Recalled for Potential Transducer Connection Reversal
GE Healthcare anesthesia systems may have reversed oxygen and air transducer connections, potentially affecting proper gas delivery. 5,372 devices worldwide are affected.
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 FDA Class I recall requires a minimum severity score of 4 per the classification system. The Class I designation indicates a serious health hazard, though no illnesses or injuries have been reported.
Plain-English summary
GE Healthcare has recalled Aisys CS2 and Avance CS2/CS2 Pro anesthesia systems due to a potential reversal of oxygen and air cylinder pressure transducer connections. The recall affects 5,372 devices with specific serial number ranges.
Reversal of the oxygen and air transducer connections could result in improper gas delivery during anesthesia administration, potentially affecting patient safety.
The affected devices have been distributed worldwide to healthcare facilities. Healthcare providers should consult the FDA recall notice to determine whether their equipment serial numbers fall within the affected ranges.
The recalled product
- Product
- GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- connection-reversal
- gas-delivery-error
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)
- 00185 through 00697
- 00700 through 00763
- 00768 through 01013
- 01016 through 01216
- 01218 through 01223
- 01225 through 01596
- 01601 through 01683
- 01685 through 01805
- 01808 through 01960
- 01964 through 01999
- 02003 through 02021
- 02026 through 02168
- 02175
- 02182 through 02308
- 02311 through 02361
- 02376 through 02405
- 02424 through 02429
- 02450 through 02456
- 02519 through 02531
- 02533 through 02539. Serial numbers starting with APWB: 00101 through 00151
Distribution
Distributed nationwide across the United States.
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