Severe FDA (Devices)·Z-1636-2025·Announced 2025-05-07

GE Healthcare CARESTATION Anesthesia Systems Ventilation Mode Failure Recall

Certain GE Healthcare CARESTATION 750 A2 anesthesia systems may not provide effective ventilation in Volume Control Ventilation mode. Users should switch to Pressure Control Ventilation or Manual ventilation modes.

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 of a medical device used in critical anesthesia delivery. Although no illnesses or injuries are reported in the source text, the failure of primary ventilation mode in an anesthesia system meets the Severe criterion for a structural/functional device defect that could result in serious patient harm.

Plain-English summary

GE Medical Systems China Co., Ltd. is recalling certain GE Healthcare CARESTATION 750 A2 anesthesia delivery systems (Model/REF 1012-9750-002). These systems will not provide effective ventilation when operating in Volume Control Ventilation (VCV) mode.

Affected units may be unable to deliver adequate ventilation in VCV mode, which could pose a risk during anesthesia delivery if the operator does not recognize the issue and switch to an alternative mode.

Effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes, or with Manual ventilation. Operators of affected systems should use these alternative ventilation modes until the equipment is serviced or replaced.

The affected systems were distributed worldwide, including throughout the United States and Puerto Rico. Affected serial numbers are listed on the FDA's recall notice at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-1636-2025.

The recalled product

Product: GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system.
Manufacturer: GE Medical Systems China Co., Ltd.
Category: Medical Device — Anesthesia Delivery System
Hazard: ventilation-failure
anesthesia-system-defect
Affected units: 217

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 00840682146470
Serial Numbers: SQS23480001WB
SQS23480002WB
SQS23480003WB
SQS23480004WB
SQS23480005WB
SQS23500002WB
SQS24510072WB
SQS24510073WB
SQS24510074WB
SQS24510075WB
SQS24510076WB
SQS24250017WB
SQS24250018WB
SQS24250019WB
SQS24370029WB
SQS24370030WB
SQS24370031WB
SQS23510004WB
SQS23370007WB

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