Agency classClass IOur severity:Severe FDA (Devices)·Z-1631-2025·Announced 2025-05-07

GE Healthcare Carestation Anesthesia Systems Ventilation Defect Recall

Certain GE Healthcare Carestation anesthesia delivery systems may fail to provide effective ventilation in Volume Control Ventilation (VCV) mode. Affected systems can still be used safely in Pressure Control Ventilation or Manual ventilation modes.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 for a critical medical device (anesthesia delivery system) where a functional defect could prevent effective patient ventilation during surgical procedures. Although no reported illnesses are stated in the source text, the potential for serious harm in an anesthesia delivery system meets the Severe criterion for Class I recalls.

Plain-English summary

GE Medical Systems China Co., Ltd. is recalling certain Carestation 620, 650, 650c, 750, and 750c anesthesia delivery systems. These systems will not provide effective ventilation when operated in Volume Control Ventilation (VCV) mode.

A total of 648 units have been distributed worldwide, including in the United States and Puerto Rico as well as international locations.

Effective ventilation can be achieved using alternative modes: Pressure Control Ventilation (PCV), Pressure Control Ventilation Volume Guarantee (PCV-VG), or Manual ventilation. Healthcare facilities should review their anesthesia delivery system operation and confirm the selected ventilation mode with their clinicians.

The recalled product

Product: GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system.
Manufacturer: GE Medical Systems China Co., Ltd.
Category: Medical Device — Anesthesia Equipment
Hazard: ventilation-failure
functional-defect
Affected units: 648

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.

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 →

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

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Same hazard · ventilation failure