GE Carestation 650 A1 anesthesia system ventilation failure
The GE Carestation 650 A1 anesthesia system fails to provide effective ventilation in Volume Control Ventilation (VCV) mode, though ventilation is available in alternative modes.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I recall of critical anesthesia system with confirmed ventilation failure in one operational mode. FDA Class I classification of this safety-critical device warrants Critical severity regardless of availability of alternative modes.
Plain-English summary
The GE Healthcare Carestation 650 A1 anesthesia delivery system (Model/REF 1012-9650-200) manufactured by GE Medical Systems China Co., Ltd. has been recalled by the FDA. Approximately 648 units have been distributed worldwide, including throughout the United States and Puerto Rico.
Certain units will not provide effective ventilation when operated in Volume Control Ventilation (VCV) mode. Effective ventilation can still be achieved using Pressure Control Ventilation (PCV) mode, Pressure Control Ventilation with Volume Guarantee (PCV-VG) mode, or Manual ventilation.
The recall is classified by the FDA as Class I, the agency's highest severity classification for medical device recalls. The recall affects units with specific serial numbers listed on the FDA's recall notice.
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
- anesthesia-system-failure
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.
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03