GE Healthcare Carestation 650 A1 Anesthesia System Ventilation
Certain GE Healthcare Carestation 650 A1 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Alternative ventilation modes or manual ventilation can be used.
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 affecting a medical device used in critical patient care (anesthesia delivery). The defect—failure to provide effective ventilation in a specific mode—creates a direct risk of serious patient harm during anesthesia, meeting the Severe classification threshold.
Plain-English summary
GE Healthcare Carestation 650 A1 anesthesia delivery systems (Model/REF 1012-9650-000) are subject to a Class I recall. Affected units will not provide effective ventilation when operating in Volume Control Ventilation (VCV) mode.
The systems can still deliver effective ventilation using Pressure Control Ventilation (PCV) mode, Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, or manual ventilation. Approximately 3,905 units have been distributed worldwide, including throughout the United States and Puerto Rico.
Healthcare facilities currently using or maintaining affected anesthesia systems should verify their unit's serial number against the recall list and transition to alternative ventilation modes. Facilities should contact GE Medical Systems China Co., Ltd., the manufacturer, for further guidance and product support.
The recalled product
- Product
- GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system.
- Manufacturer
- GE Medical Systems China Co., Ltd.
- Hazard
- ventilation-failure
- inadequate-anesthesia-delivery
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 00840682103947
- Serial Numbers: SM724310010MA
- SM723370006MA
- SM723080015MA
- SM724440001MA
- SM723370003MA
- SM723240009MA
- SM723360010MA
- SM723360011MA
- SM723360012MA
- SM723360013MA
- SM723360014MA
- SM723360015MA
- SM723360016MA
- SM723360017MA
- SM724100019MA
- SM724500002MA
- SM724500003MA
- SM724500004MA
- SM724500005MA
Distribution
Distributed nationwide across the United States.
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