GE Healthcare Carestation 650c A1 Anesthesia System Ventilation Failure
GE Healthcare is recalling certain Carestation 650c A1 anesthesia systems worldwide because they may not provide effective ventilation in Volume Control Ventilation mode, limiting patient ventilation options during anesthesia delivery.
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. Per the severity rubric, FDA Class I recalls must score at minimum 4 (Severe), regardless of whether illness has been reported. A ventilation system malfunction in an anesthesia delivery device presents a serious risk to patient safety during critical medical procedures.
Plain-English summary
GE Medical Systems China Co., Ltd. is recalling the GE Healthcare Carestation 650c A1 anesthesia delivery system (Model/REF Number 1012-9655-200, GTIN 00195278439543). Nineteen units have been identified with this issue and distributed worldwide, including across the United States and Puerto Rico.
The recalled systems will not provide effective ventilation when operating in Volume Control Ventilation (VCV) mode. This limitation restricts the ventilation delivery methods available to anesthesia providers during patient care.
Affected systems can still deliver effective ventilation using Pressure Control Ventilation (PCV) mode, Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, or Manual ventilation. Healthcare facilities using these systems should verify that alternative ventilation modes remain available and functional for patient use.
Facilities that have received units with the following serial numbers should contact GE Medical Systems: SM824450008WD, SM824450009WD, SM824450010WD, SM824450011WD, SM824450012WD, SM824450013WD, SM824450014WD, SM824450015WD, SM823300001MD, SM824360002WD, SM824360004WD, SM824360005WD, SM824360006WD, SM824360007WD, SM825020002MD, SM825020003MD, SM825020004MD, SM825020005MD, and SM825020006MD.
The recalled product
- Product
- GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system.
- Manufacturer
- GE Medical Systems China Co., Ltd.
- Hazard
- ventilation-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 00195278439543
- Serial Numbers: SM824450008WD
- SM824450009WD
- SM824450010WD
- SM824450011WD
- SM824450012WD
- SM824450013WD
- SM824450014WD
- SM824450015WD
- SM823300001MD
- SM824360002WD
- SM824360004WD
- SM824360005WD
- SM824360006WD
- SM824360007WD
- SM825020002MD
- SM825020003MD
- SM825020004MD
- SM825020005MD
- SM825020006MD.
Distribution
Distributed nationwide across the United States.
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