FDA Device recall Z-0009-2014
GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation
- FDA Device
- Class I
- terminated
- Published 2013-10-23
On 2013-10-23 the FDA classified a Class I recall of GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation by Ge Healthcare, citing GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating in Pressure Control Ventilation….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0009-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-09-16 |
| Published | 2013-10-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
Reason
GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating in Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit). Exposure to excessiv
Identifiers
| code_info | Mfg Lot or Serial # ANBR01060 ANAQ01557 ANBQ01421 ANBQ01418 ANBQ01419 ANBQ01420 ANBR01342 ANBR00292 ANBR00289…Mfg Lot or Serial # ANBR01060 ANAQ01557 ANBQ01421 ANBQ01418 ANBQ01419 ANBQ01420 ANBR01342 ANBR00292 ANBR00289 ANBR00293 ANBR00290 ANBR00291 ANBR00294 ANBR00295 ANBQ01522 ANBQ01520 ANBQ01524 ANBQ01521 ANBQ01523 ANBQ02209 ANBQ02212 ANBQ02213 ANBQ02210 ANBQ02211 ANBS00535 ANBR01079 ANBR01078 ANBR01080 ANAQ00842 ANBR01053 ANBR01054 ANBQ01015 ANBQ01965 ANBQ01480 ANBQ01966 ANBQ01484 ANBS00304 ANBS00305 ANAR00675 ANAR05794 ANAR05793 ANBQ01751 ANBR00248 ANAS00596 ANAS00593 ANBQ01055 ANBQ01052 ANBQ01056 ANBQ01051 ANBQ01053 ANBQ01054 ANAQ01176 ANAQ01177 ANAR05091 ANAR05174 ANBQ00785 ANBQ00786 ANBR00256 ANBQ01664 ANBQ01259 ANBQ01258 APKS00537 APKS00538 ANAQ01781 ANBQ01041 ANBQ00109 ANBR02305 ANBR02304 ANBR02306 ANBR02307 ANAQ01376 ANAQ01377 ANAS00332 ANAS00331 ANAS01022 ANAS01024 ANAS01023 ANAS01019 ANAS01025 ANAS01016 ANAS01017 ANAS01020 ANAS01018 ANAS01021 ANAS01017 ANAS01022 ANAS01016 ANAS01018 ANAS01024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0009-2014%22
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