GE Healthcare Carestation Anesthesia Systems Ventilation Defect Recall
Certain GE Healthcare Carestation anesthesia delivery systems may fail to provide effective ventilation in Volume Control Ventilation (VCV) mode. Affected systems can still be used safely in 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 for a critical medical device (anesthesia delivery system) where a functional defect could prevent effective patient ventilation during surgical procedures. Although no reported illnesses are stated in the source text, the potential for serious harm in an anesthesia delivery system meets the Severe criterion for Class I recalls.
Plain-English summary
GE Medical Systems China Co., Ltd. is recalling certain Carestation 620, 650, 650c, 750, and 750c anesthesia delivery systems. These systems will not provide effective ventilation when operated in Volume Control Ventilation (VCV) mode.
A total of 648 units have been distributed worldwide, including in the United States and Puerto Rico as well as international locations.
Effective ventilation can be achieved using alternative modes: Pressure Control Ventilation (PCV), Pressure Control Ventilation Volume Guarantee (PCV-VG), or Manual ventilation. Healthcare facilities should review their anesthesia delivery system operation and confirm the selected ventilation mode with their clinicians.
The recalled product
- Product
- GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system.
- Manufacturer
- GE Medical Systems China Co., Ltd.
- Hazard
- ventilation-failure
- functional-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 00195278439529
- Serial Numbers: SM724450001MD
- SM724450002MD
- SM724450003MD
- SM724450004MD
- SM724450005MD
- SM724450006MD
- SM724450007MD
- SM724450008MD
- SM724450009MD
- SM724450010MD
- SM724450011MD
- SM724450012MD
- SM724450013MD
- SM724450005WD
- SM724450006WD
- SM724450007WD
- SM724450008WD
- SM724450009WD
- SM724450010WD
Distribution
Distributed nationwide across the United States.
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