United StatesAffected products are Aisys, Aisys CS2, Aisys CS2 with Et Control anesthesia systems (Part Numbers 1011-9050-000; 1011-9055-000; 1011-9000-000) and the Et Control software option/FRU (Part Numbers 1011-8000-000-S, 5700665), identifiable by the listed serial numbers and UDI‑DI 00840682102292 and distributed worldwide including the U.S. They were recalled because certain electronic gas mixer assemblies can automatically switch to Alternate O2 control, delivering 100% oxygen, interrupting anesthetic agent delivery and requiring clinician intervention, which may reduce anesthetic effect.
What's being recalled
Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
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
Recalling firm: Datex-Ohmeda, Inc., Madison, WI, United States.
How to identify it
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 APWE02051 APWE02057 APWE02058 APWE02059 APWE01912 APWF00308 APWF00309 APWE01990 APWW00228 APWU01342 APWE01989 APWT00240 APWZ00855 APWF00395 APWF00339 APWX02985 APWX02993 APWF00190 APWE01968 APWC01311 APWF00456 APWY01027 APWY01033 APWY01034 APWE01960 APWF00197 APWE01972 APWE01973 APWC01482 APWF00304 APWE01933 APWE01935 APWF00460 APWZ01205 APWF00237 APWE01998 APWE01999 APWE01971 APWF00179 APWF00180 APWF00181 APWF00182 APWF00183 APWD02593 APWD02605 APWC03541 APWF00294 APWF00311 APWV02707 APWV02725 APWV02729 APWC02024 APWC02122 APWT02371 APWF00220 APWF00221 APWF00222 APWF00223 APWF00224 APWF00225 APWF00226 APWF00155 APWE01967 APWY02790 APWC01093 APWF00397 APWF00398 APWF00184 APWC01293 APWC01297 APWB01830 APWW01733 APWF00358 APWU02297 APWU02303 APWF00257 APWF00258 APWF00259 APWE01995 APWF00301 APWF00302 APWF00303 APWZ01218 APWE01821 APWE01823 APWE01887 APWE01888 APWE01889 APWE01890 APWE01891 APWC01262 APWC01292 APWV01345 APWF00207 APWF00208 APWF00238 APWF00316 APWF00317 APWF00318…
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada