The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1626-2025·Announced 2025-05-07

GE Healthcare Carestation 620 SE Anesthesia System Ventilation Defect Recall

GE Healthcare is recalling certain Carestation 620 SE anesthesia systems (27 units) because they may not 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: The FDA classified this as a Class I recall. Although no injuries or illnesses are reported in the source text, the defect affects critical ventilation functionality in a medical device used during anesthesia delivery. Per the rubric, FDA Class I recalls with medical device context warrant a Severe (4) rating when the hazard directly impacts patient safety during active clinical use.

Plain-English summary

GE Medical Systems China Co., Ltd. is recalling 27 units of the GE Healthcare Carestation 620 SE anesthesia system (Model/REF Number 1012-9620-012) due to a defect in ventilation functionality.

The affected systems will not provide effective ventilation when operating in Volume Control Ventilation (VCV) mode. However, effective ventilation can be achieved using Pressure Control Ventilation (PCV) mode, Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, or Manual ventilation.

The affected units have been distributed worldwide, including throughout the United States and Puerto Rico. Customers using affected systems should verify that they are operating in PCV, PCV-VG, or Manual ventilation modes, or contact the manufacturer for further guidance.

For a complete list of affected serial numbers and additional information, contact GE Medical Systems China Co., Ltd. or refer to FDA recall number Z-1626-2025.

The recalled product

Product
GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system.
Manufacturer
GE Medical Systems China Co., Ltd.
Category
Medical Device — Anesthesia Delivery System
Hazard
Affected units
27

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 00195278569677
  • Serial Numbers: SM624250018WC
  • SM624250019WC
  • SM624500025WC
  • SM624500026WC
  • SM624500027WC
  • SM624290020WC
  • SM624290021WC
  • SM623470001WC
  • SM623470002WC
  • SM623470003WC
  • SM623470004WC
  • SM623470005WC
  • SM623470006WC
  • SM623470007WC
  • SM623470008WC
  • SM623470009WC
  • SM623470010WC
  • SM623470011WC
  • SM623470012WC

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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