The Recall Desk
SevereFDA (Devices)·Z-1634-2025·Announced 2025-05-07

GE Healthcare Carestation 650c A1 Anesthesia System Ventilation Failure

GE Healthcare is recalling certain Carestation 650c A1 anesthesia systems worldwide because they may not provide effective ventilation in Volume Control Ventilation mode, limiting patient ventilation options during anesthesia delivery.

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. Per the severity rubric, FDA Class I recalls must score at minimum 4 (Severe), regardless of whether illness has been reported. A ventilation system malfunction in an anesthesia delivery device presents a serious risk to patient safety during critical medical procedures.

Plain-English summary

GE Medical Systems China Co., Ltd. is recalling the GE Healthcare Carestation 650c A1 anesthesia delivery system (Model/REF Number 1012-9655-200, GTIN 00195278439543). Nineteen units have been identified with this issue and distributed worldwide, including across the United States and Puerto Rico.

The recalled systems will not provide effective ventilation when operating in Volume Control Ventilation (VCV) mode. This limitation restricts the ventilation delivery methods available to anesthesia providers during patient care.

Affected systems can still deliver effective ventilation using Pressure Control Ventilation (PCV) mode, Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, or Manual ventilation. Healthcare facilities using these systems should verify that alternative ventilation modes remain available and functional for patient use.

Facilities that have received units with the following serial numbers should contact GE Medical Systems: SM824450008WD, SM824450009WD, SM824450010WD, SM824450011WD, SM824450012WD, SM824450013WD, SM824450014WD, SM824450015WD, SM823300001MD, SM824360002WD, SM824360004WD, SM824360005WD, SM824360006WD, SM824360007WD, SM825020002MD, SM825020003MD, SM825020004MD, SM825020005MD, and SM825020006MD.

The recalled product

Product
GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system.
Manufacturer
GE Medical Systems China Co., Ltd.
Category
Medical Device — Anesthesia System
Hazard
Affected units
19

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 00195278439543
  • Serial Numbers: SM824450008WD
  • SM824450009WD
  • SM824450010WD
  • SM824450011WD
  • SM824450012WD
  • SM824450013WD
  • SM824450014WD
  • SM824450015WD
  • SM823300001MD
  • SM824360002WD
  • SM824360004WD
  • SM824360005WD
  • SM824360006WD
  • SM824360007WD
  • SM825020002MD
  • SM825020003MD
  • SM825020004MD
  • SM825020005MD
  • SM825020006MD.

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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