FDA Device recall Z-0678-2016
GE Healthcare, Aestiva 7900, 1006-9305-000
- FDA Device
- Class II
- terminated
- Published 2016-01-27
On 2016-01-27 the FDA classified a Class II recall of GE Healthcare, Aestiva 7900, 1006-9305-000 by Ge Medical Systems, citing the Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0678-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-15 |
| Published | 2016-01-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Medical Systems |
| Distribution | US |
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 surgical procedures.
Reason
The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.
Identifiers
| code_info | AMRU01022 AMRU01023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0678-2016%22
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