FDA Device recall Z-0681-2016
GE Healthcare, Aisys CS2,1011-9050-000
- FDA Device
- Class II
- terminated
- Published 2016-01-27
On 2016-01-27 the FDA classified a Class II recall of GE Healthcare, Aisys CS2,1011-9050-000 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-0681-2016 |
| 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, 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). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.
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 | APWU00723 APWU00724 APWU01057 APWU01058 APWU01059 APWU01785 APWU01827 APWU01988 APWU01989 APWU01990 APWU01991…APWU00723 APWU00724 APWU01057 APWU01058 APWU01059 APWU01785 APWU01827 APWU01988 APWU01989 APWU01990 APWU01991 APWU01992 APWU01993 APWU01994 APWU01995 APWU01996 APWU01997 APWU01576 APWU01577 APWU01578 APWU00707 APWU00708 APWU00709 APWU00710 APWU00711 APWU00712 APWU00713 APWU01486 APWU01487 APWU01488 APWU01489 APWU01490 APWU01491 APWU01492 APWU01493 APWU01494 APWU01495 APWU01825 APWU01909 APWU02017 APWU02018 APWU02019 APWU02020 APWU01054 APWU01055 APWU01056 APWU00840 APWU00841 APWU00842 APWU00843 APWU00844 APWU00845 APWU00846 APWU00847 APWU01608 APWU01609 APWU01610 APWU01611 APWU01612 APWU01613 APWU01614 APWU01615 APWU02066 APWU02067 APWU00728 APWU00729 APWU00730 APWU00751 APWU00752 APWU00753 APWU00754 APWU00755 APWU01595 APWU01240 APWU01241 APWU01242 APWU01243 APWU01244 APWU01359 APWU01949 APWU01410 APWU01411 APWU01412 APWU00767 APWU00768 APWU00769 APWU01131 APWU01132 APWU01133 APWU01340 APWU01341 |
|---|
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-0681-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.