FDA Device recall Z-3192-2026
Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field repla…
- FDA Device
- Class II
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class II recall of Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field repla… by Datex Ohmeda, citing anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 1….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3192-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-30 |
| Published | 2026-09-23 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | Datex Ohmeda |
| Distribution | US |
Product
Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field replaceable unit (FRU) part numbers: 1011-8000-000-S, 5700665
Reason
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician intervention. If this is not provided, the patient may experience decreased anesthetic agent effect.
Identifiers
| code_info | Serial Numbers: 801042711 801031045 801031926 801045423 801011743 801090568 801128677 801011276-1 801011276-10 80101127…Serial Numbers: 801042711 801031045 801031926 801045423 801011743 801090568 801128677 801011276-1 801011276-10 801011276-11 801011276-12 801011276-13 801011276-14 801011276-15 801011276-2 801011276-3 801011276-4 801011276-5 801011276-6 801011276-7 801011276-8 801011276-9 801078342-1 801078342-10 801078342-11 801078342-12 801078342-13 801078342-14 801078342-15 801078342-16 801078342-17 801078342-18 801078342-19 801078342-2 801078342-20 801078342-21 801078342-22 801078342-23 801078342-24 801078342-25 801078342-26 801078342-27 801078342-28 801078342-29 801078342-3 801078342-30 801078342-4 801078342-5 801078342-6 801078342-7 801078342-8 801078342-9 801102924 801108227 801113705 801114965 801084897 801003006 801004394 801071735 801016238 801050584 801051585 801064585 801013238 801013095 801043259 801088072 801014199 801006762 801052860 801023283 801110573 801064058 801080036 801126195 801064184-1 801064184-2 801059320-1 801059320-2 801091614 801028252 801051344 801030002 800988180 801111226 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
Other recalls by Datex Ohmeda
- Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
FDA Device · Class II · 2026-09-23 · Datex Ohmeda - Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
FDA Device · Class II · 2026-09-23 · Datex Ohmeda - Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
FDA Device · Class II · 2026-09-23 · Datex Ohmeda - Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Product Identifiers: M…
FDA Device · Class I · 2026-06-24 · Datex Ohmeda - Giraffe Stand-alone Infant Resuscitation System
FDA Device · Class I · 2026-06-24 · Datex Ohmeda
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3192-2026%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.