The Recall Desk
SevereFDA (Devices)·Z-1635-2025·Announced 2025-05-07

GE Healthcare CARESTATION 750 Anesthesia System Volume Control Ventilation Failure

Certain GE Healthcare CARESTATION 750 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Affected systems can deliver ventilation through alternative 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: This is an FDA Class I recall of a critical medical device (anesthesia system) that directly affects patient ventilation during surgery. Although no illnesses or injuries are explicitly reported in the source, the potential for harm is significant because the device is used in the operating room where ventilation failure could pose serious risk to patients. Per the rubric, FDA Class I recalls are never scored below 4, and the severity label matches the score.

Plain-English summary

GE Healthcare CARESTATION 750 A1 anesthesia delivery systems (Model/REF 1012-9750-000) are subject to a recall due to a ventilation failure. Certain units will not provide effective ventilation when operating in Volume Control Ventilation (VCV) mode.

The affected systems can achieve effective ventilation through alternative operating modes: Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG), as well as through manual ventilation. Approximately 4,339 units have been distributed worldwide, including to the United States, Puerto Rico, and numerous international locations.

Patients and healthcare providers using affected systems should switch to PCV, PCV-VG, or manual ventilation modes rather than VCV mode. Users should contact GE Healthcare or their service representative for further guidance, or visit the FDA recall notice at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-1635-2025.

The recalled product

Product
GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system.
Manufacturer
GE Medical Systems China Co., Ltd.
Category
Medical Device — Anesthesia Delivery System
Hazard
Affected units
4,358

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 00840682145596
  • Serial Numbers: SQS24500010MA
  • SQS24500011MA
  • SQS24500012MA
  • SQS24500013MA
  • SQS24500014MA
  • SQS24500015MA
  • SQS24500016MA
  • SQS24500017MA
  • SQS24130011MA
  • SQS24130012MA
  • SQS24130013MA
  • SQS24130014MA
  • SQS24130015MA
  • SQS24130016MA
  • SQS24130017MA
  • SQS24130018MA
  • SQS24170062MA
  • SQS24170063MA
  • SQS24170064MA

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.

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Same hazard · ventilation failure

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