Agency classClass IIOur severity:Severe FDA (Devices)·Z-0677-2016·Announced 2016-01-27

GE Aespire Anesthesia Systems Recalled for Potential Barotrauma Risk

GE Medical Systems is recalling Aespire 7900 and Aespire View anesthesia systems because a stuck valve could cause excessive pressure and 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 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 recall is classified as FDA Class II and involves a risk of barotrauma (significant injury) to patients, which aligns with the 'Severe' criteria for significant injury reports or high-risk medical device defects.

Plain-English summary

GE Medical Systems, LLC is recalling 1,081 units of the GE Datex-Ohmeda Aespire 7900 and Aespire View anesthesia systems. These devices are intended to provide general inhalation anesthesia and ventilatory support to patients. The recall covers units distributed nationwide in the United States (excluding New Hampshire, Vermont, and Wyoming) and internationally to numerous countries.

The recall is due to a defect in the Drive Gas Check Valve, which could become stuck in a fixed open position. This malfunction could cause pressure to build in the mechanical ventilation cycle, resulting in excessive or prolonged pressure in the patient breathing circuit. If left unresolved, this condition could potentially result in barotrauma to the patient.

Healthcare facilities and users should contact GE Medical Systems for instructions on how to address the defect. The source text does not specify a particular action such as stopping use immediately, but the risk of barotrauma indicates a significant safety concern for patients undergoing ventilation.

The recalled product

Product: GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range…
Manufacturer: GE Medical Systems, LLC
Category: Medical Device — Anesthesia Systems
Hazard: barotrauma
excessive-pressure
Affected units: 1,081

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