medical Class I Updated 2025-05-07

GE Medical Systems China Co., Ltd. recalls GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-965

Recalled Product

GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000

Hazard / Issue

GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN 00840682103954, Serial Numbers: SM823080001MA, SM823080002MA, SM823080003MA, SM823080004MA, SM824210002WA, SM824210003WA, SM824210004WA, SM824230005WA, SM824230006WA, SM823440005WA, SM823440006WA, SM823440007WA, SM823440008WA, SM823050001WA, SM823050002WA, SM823050003WA, SM823050004WA, SM823050005WA, SM823060001WA, SM823060002WA, SM824030001MA, SM824030002MA, SM824030003MA, SM824030004MA, SM824030005MA, SM824030006MA, SM824030007MA, SM824030008MA, SM824030009MA, SM824030010MA, SM823120001MA, SM824320007WA, SM823010001WA, SM823430004WA, SM824050003MA, SM824050004MA, SM824050005MA, SM824050006MA, SM824050007MA, SM824050001WA, SM824050002WA, SM823230001MA, SM823230002MA, SM824040001WA, SM824450010WA, SM823410001WA, SM823410002WA, SM823420003WA, SM823480001WA, SM823170001MA, SM823170002MA, SM823170003MA, SM823170004MA, SM823170005MA, SM823170006MA, SM823280001MA, SM823280002MA, SM823280003MA, SM824430009WA, SM823370001MA, SM823370002MA, SM824410006MA, SM824410007MA, SM824410008MA, SM824440009MA, SM824440010MA, SM824440011MA, SM824440012MA, SM824440013MA.
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