Agency classClass IIOur severity:High FDA (Devices)·Z-0681-2016·Announced 2016-01-27

GE Healthcare Anesthesia Systems Recalled for Potential Barotrauma Risk

GE Medical Systems is recalling certain Aisys and Avance anesthesia systems because a stuck valve could cause excessive pressure in the patient breathing circuit, potentially leading to barotrauma.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of serious injury (barotrauma) from a medical device defect, but no reported illnesses or injuries are stated in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Medical Systems, LLC is recalling 2,627 units of GE Healthcare Aisys CS2, Avance Amingo, and Avance CS2 anesthesia systems. The recall is due to a defect in the Drive Gas Check Valve, which could become stuck in a fixed open position.

If the valve remains stuck open, pressure could build up during the mechanical ventilation cycle. This could result in excessive or prolonged pressure in the patient breathing circuit, potentially causing barotrauma to the patient.

The affected devices are intended to provide general inhalation anesthesia and ventilatory support to neonatal, pediatric, and adult patients. The recall covers units distributed worldwide, including the United States (excluding New Hampshire, Vermont, and Wyoming) and numerous international locations. Healthcare facilities should contact GE Medical Systems for instructions on how to address the defect.

The recalled product

Product: GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avance CS2, 1009-9050-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult).…
Manufacturer: GE Medical Systems, LLC
Category: Medical Device — Anesthesia Systems
Hazard: barotrauma
excessive-pressure
Affected units: 2,627

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Part of a larger recall action

This product is one of 6 recalled by GE Medical Systems, LLC 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 6 products in this recall →

Same manufacturer · GE Medical Systems, LLC

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Same hazard · barotrauma