Agency classClass IOur severity:Severe FDA (Devices)·Z-1625-2025·Announced 2025-05-07

GE Healthcare CARESTATION 620 A2 Anesthesia System Ventilation Failure

Certain GE Healthcare CARESTATION anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation (VCV) 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 medical device recall. A defect in an anesthesia system's primary ventilation mode creates significant potential for patient harm in a critical-care setting, even though no hospitalizations or adverse events are reported in the source text.

Plain-English summary

GE Medical Systems China Co., Ltd. is recalling certain CARESTATION anesthesia delivery systems, including models 620, 650, 650c, 750, and 750c with the specific reference number 1012-9620-002, due to a ventilation delivery defect.

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

Approximately 1,483 units have been distributed worldwide, including throughout the United States and Puerto Rico. Healthcare facilities and medical professionals using these systems should use PCV, PCV-VG, or Manual ventilation modes in place of VCV mode until the systems are serviced.

Healthcare providers with affected units should contact GE Medical Systems for guidance on corrective action.

The recalled product

Product: GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.
Manufacturer: GE Medical Systems China Co., Ltd.
Category: Medical Device — Anesthesia Delivery System
Hazard: ventilation-failure
device-malfunction
Affected units: 1,483

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 00840682124546
Serial Numbers: SM623510024WB
SM623510028WB
SM623510029WB
SM623510030WB
SM623510031WB
SM623510032WB
SM623510025WB
SM623510026WB
SM623510027WB
SM624390041WB
SM624390042WB
SM623510033WB
SM623510034WB
SM624220006WB
SM624220008WB
SM623160001WB
SM623160002WB
SM624120009WB
SM624120010WB

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