Agency classClass IOur severity:Severe FDA (Devices)·Z-1638-2025·Announced 2025-05-07

GE Healthcare CARESTATION Anesthesia Systems may not ventilate properly

GE Healthcare is recalling certain CARESTATION anesthesia systems that may fail to provide effective ventilation in Volume Control Ventilation mode. Alternative ventilation modes remain functional.

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: This is an FDA Class I recall of a medical device used in anesthesia delivery. Class I recalls by definition carry the potential for serious adverse health consequences, and a ventilation failure in an anesthesia system poses significant risk of harm to patients even though no illnesses or injuries are reported in the source text.

Plain-English summary

GE Healthcare is recalling certain CARESTATION 620, 650, 650c, 750, and 750c anesthesia delivery systems worldwide, including in the United States and Puerto Rico. These systems will not provide effective ventilation when operating in Volume Control Ventilation (VCV) mode.

The affected anesthesia systems are GE Medical Systems China Co., Ltd. Model/REF Number 1012-9755-002 units with serial numbers SQT23170001WB, SQT23430001WB, SQT23230001WB, SQT24110001WB, and SQT24020001WB (GTIN 00840682146463). Five units have been distributed worldwide.

In affected systems, effective ventilation can still be achieved using Pressure Control Ventilation (PCV) mode, Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, or Manual ventilation. Healthcare facilities using these anesthesia systems should verify their ventilation mode settings and contact GE Healthcare for repair or replacement.

The recalled product

Product: GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system.
Manufacturer: GE Medical Systems China Co., Ltd.
Category: Medical Device — Anesthesia Delivery System
Hazard: ventilation-failure
inadequate-anesthesia-delivery
Affected units: 5

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 (6)

GTIN 00840682146463
Serial Numbers: SQT23170001WB
SQT23430001WB
SQT23230001WB
SQT24110001WB
SQT24020001WB

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