FDA Device recall Z-3189-2026
Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
- FDA Device
- Class II
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class II recall of Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000 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-3189-2026 |
| 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
Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
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 | UDI-DI: 00840682102292; Serial Numbers: APWC01722 APWF00169 APWF00170 APWF00173 APWF00174 APWF00111 APWF00368 APWF00402…UDI-DI: 00840682102292; Serial Numbers: APWC01722 APWF00169 APWF00170 APWF00173 APWF00174 APWF00111 APWF00368 APWF00402 APWF00465 APWF00467 APWF00468 APWF00469 APWF00470 APWF00471 APWF00472 APWF00473 APWF00474 APWF00475 APWF00476 APWF00477 APWT00394 APWC01107 APWF00436 APWE01910 APWE01911 APWV00635 APWW01464 APWW01625 APWF00380 APWF00381 APWF00382 APWY00358 APWF00359 APWF00313 APWE01925 APWV02342 APWE01915 APWF00458 APWF00433 APWD02646 APWC01330 APWC01339 APWC01340 APWF00279 APWF00280 APWF00281 APWF00282 APWF00283 APWF00284 APWF00285 APWF00286 APWF00287 APWF00288 APWF00289 APWF00290 APWF00262 APWF00312 APWX00800 APWX00804 APWF00138 APWF00466 APWE01974 APWF00396 APWF00297 APWF00298 APWF00299 APWF00300 APWF00296 APWT00798 APWA02035 APWF00239 APWF00241 APWF00242 APWF00243 APWF00244 APWF00245 APWF00246 APWF00247 APWF00248 APWF00249 APWF00250 APWF00251 APWF00252 APWF00253 APWF00254 APWF00255 APWF00256 APWF00405 APWF00406 APWF00459 APWF00145 APWF00146 APWF00147 APWF00149 APWF00150 APWF00346 |
|---|
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 - 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 · 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 - 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-3189-2026%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.