The Recall Desk
SevereFDA (Devices)·Z-1632-2025·Announced 2025-05-07

GE Healthcare CARESTATION 650C A1 Anesthesia System Ventilation Recall

GE Healthcare CARESTATION 650C A1 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Ventilation can be achieved using alternate 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 as Class I, which per the rubric requires a minimum score of 4. The hazard involves failure of a critical ventilation function in an anesthesia delivery system, a direct patient safety risk in an operating environment.

Plain-English summary

GE Medical Systems China Co., Ltd. is recalling certain GE Healthcare CARESTATION 650C A1 anesthesia delivery systems (Model/REF Number 1012-9655-000). The affected units will not provide effective ventilation when operating in Volume Control Ventilation (VCV) mode.

Affected systems can achieve effective ventilation through alternative modes: Pressure Control Ventilation (PCV), Pressure Control Ventilation Volume Guarantee (PCV-VG), or Manual ventilation. A total of 69 units have been distributed worldwide, including throughout the United States and Puerto Rico, as well as internationally.

Facilities using affected systems should verify their device serial numbers against the recall list and ensure clinical staff are aware of the ventilation limitation. Users should continue relying on PCV, PCV-VG, or manual ventilation modes until the device is serviced or replaced.

This is an FDA Class I recall.

The recalled product

Product
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.
Manufacturer
GE Medical Systems China Co., Ltd.
Category
Medical Device — Anesthesia System
Hazard
Affected units
69

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 00840682103954
  • Serial Numbers: SM823080001MA
  • SM823080002MA
  • SM823080003MA
  • SM823080004MA
  • SM824210002WA
  • SM824210003WA
  • SM824210004WA
  • SM824230005WA
  • SM824230006WA
  • SM823440005WA
  • SM823440006WA
  • SM823440007WA
  • SM823440008WA
  • SM823050001WA
  • SM823050002WA
  • SM823050003WA
  • SM823050004WA
  • SM823050005WA
  • SM823060001WA

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 15 products in this recall →

Related recalls

Same manufacturer · GE Medical Systems China Co., Ltd.

See all →

Same hazard · ventilation failure

See all →