Agency classClass IIOur severity:High FDA (Devices)·Z-0678-2016·Announced 2016-01-27

GE Healthcare Aestiva 7900 Ventilator Recall for Stuck Valve Risk

GE Medical Systems is recalling two Aestiva 7900 ventilators 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 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 involves a risk-of-harm product (barotrauma) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

GE Medical Systems, LLC is recalling two units of the GE Healthcare Aestiva 7900 ventilator (model 1006-9305-000). This device is a microprocessor-based, electronically controlled, pneumatically driven ventilator used in Datex-Ohmeda Aestiva/5 anesthesia systems to provide patient ventilation during surgical procedures.

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

The affected units were distributed worldwide, including nationwide in the United States (excluding New Hampshire, Vermont, and Wyoming) and in numerous international locations. The source text does not specify instructions for consumers or healthcare providers regarding the immediate handling of these devices.

The recalled product

Product: GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during…
Manufacturer: GE Medical Systems, LLC
Category: Medical Device — Ventilator
Hazard: barotrauma
excessive-pressure
Affected units: 2

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 (1)

AMRU01022 AMRU01023

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 →

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