GE Healthcare CARESTATION Anesthesia Systems Volume Control Ventilation Failure
GE Healthcare CARESTATION anesthesia delivery systems may fail to provide effective ventilation in Volume Control Ventilation mode. Affected units can deliver ventilation through Pressure Control Ventilation 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: The FDA classified this recall as Class I. A Class I defect affecting anesthesia delivery systems—critical life-support equipment—presents potential for serious patient harm including inadequate ventilation during surgery. Per the rubric, FDA Class I recalls score at minimum 4.
Plain-English summary
GE Healthcare CARESTATION 650C A2 (Model/REF 1012-9655-002) anesthesia systems are being recalled because certain units will not provide effective ventilation when operating in Volume Control Ventilation (VCV) mode. The affected anesthesia delivery systems are manufactured by GE Medical Systems China Co., Ltd.
Effective ventilation can be achieved through alternative ventilation modes on these systems: Pressure Control Ventilation (PCV), Pressure Control Ventilation Volume Guarantee (PCV-VG), or manual ventilation. Fifteen units have been distributed worldwide, including throughout the United States and Puerto Rico.
Users of affected CARESTATION anesthesia systems should ensure that patients are ventilated using Pressure Control Ventilation modes or manual ventilation rather than Volume Control Ventilation mode. For specific unit identification, affected serial numbers include: SM823250002WB, SM823250003WB, SM824100001WB, SM824100002WB, SM823080001WB, SM823080002WB, SM823250001WB, SM824380004WB, SM823140001WB, SM824410006WB, SM824410007WB, SM824410008WB, SM824380005WB, SM823460001WB, and SM823460002WB.
The recalled product
- Product
- GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system.
- Manufacturer
- GE Medical Systems China Co., Ltd.
- Affected units
- 15
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 (16)
- GTIN 00840682124539
- Serial Numbers: SM823250002WB
- SM823250003WB
- SM824100001WB
- SM824100002WB
- SM823080001WB
- SM823080002WB
- SM823250001WB
- SM824380004WB
- SM823140001WB
- SM824410006WB
- SM824410007WB
- SM824410008WB
- SM824380005WB
- SM823460001WB
- SM823460002WB.
Distribution
Part of a larger recall action
This product is one of 15 recalled by GE Medical Systems China Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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