The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1628-2025·Announced 2025-05-07

GE Healthcare Carestation 650 A1 Anesthesia System Ventilation

Certain GE Healthcare Carestation 650 A1 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Alternative ventilation modes or manual ventilation can be used.

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 affecting a medical device used in critical patient care (anesthesia delivery). The defect—failure to provide effective ventilation in a specific mode—creates a direct risk of serious patient harm during anesthesia, meeting the Severe classification threshold.

Plain-English summary

GE Healthcare Carestation 650 A1 anesthesia delivery systems (Model/REF 1012-9650-000) are subject to a Class I recall. Affected units will not provide effective ventilation when operating in Volume Control Ventilation (VCV) mode.

The systems can still deliver effective ventilation using Pressure Control Ventilation (PCV) mode, Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, or manual ventilation. Approximately 3,905 units have been distributed worldwide, including throughout the United States and Puerto Rico.

Healthcare facilities currently using or maintaining affected anesthesia systems should verify their unit's serial number against the recall list and transition to alternative ventilation modes. Facilities should contact GE Medical Systems China Co., Ltd., the manufacturer, for further guidance and product support.

The recalled product

Product
GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system.
Manufacturer
GE Medical Systems China Co., Ltd.
Category
Medical Device — Anesthesia Delivery System
Hazard
Affected units
4,036

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 00840682103947
  • Serial Numbers: SM724310010MA
  • SM723370006MA
  • SM723080015MA
  • SM724440001MA
  • SM723370003MA
  • SM723240009MA
  • SM723360010MA
  • SM723360011MA
  • SM723360012MA
  • SM723360013MA
  • SM723360014MA
  • SM723360015MA
  • SM723360016MA
  • SM723360017MA
  • SM724100019MA
  • SM724500002MA
  • SM724500003MA
  • SM724500004MA
  • SM724500005MA

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 →

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

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