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U.S. Department of Health and Human Services

Class 2 Device Recall Aisys

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 Class 2 Device Recall Aisyssee related information
Date Initiated by FirmJuly 30, 2026
Date PostedSeptember 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3189-2026
Recall Event ID 99649
510(K)NumberK172045 
Product Classification Gas-machine, anesthesia - Product Code BSZ
ProductAisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
Code Information 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 APWF00319 APWF00320 APWF00321 APWF00322 APWF00323 APWF00324 APWF00325 APWE01994 APWE01996 APWE01997 APWF00151 APWF00152 APWF00153 APWF00154 APWF00457 APWD01692 APWF00407 APWE00534 APWF00194 APWF00326 APWF00327 APWF00328 APWF00329 APWF00330 APWF00331 APWF00332 APWF00333 APWF00334 APWF00335 APWY01203 APWC01449 APWF00369 APWF00305 APWF00307 APWX01221 APWY02445 APWC02036 APWF00340 APWC01226 APWF00361 APWF00362 APWF00399 APWF00400 APWF00401 APWF00112 APWV01020 APWC01174 APWE01441 APWF00134 APWF00135 APWF00136 APWT00828 APWC02088 APWC01284 APWV02602 APWF00263 APWF00264 APWF00265 APWF00266 APWF00267 APWF00268 APWF00269 APWF00270 APWF00271 APWF00272 APWC02592 APWU00484 APWF00360 APWF00494 APWF00495 APWT02203 APWF00291 APWF00482 APWE02001 APWE02002 APWE02003 APWD00679 APWE02013 APWE02018 APWE02024 APWE02025 APWE01966 APWE01970 APWF00195 APWF00409 APWE01987 APWE01988 APWF00336 APWF00417 APWF00414 APWE02036 APWE02037 APWE02038 APWC01196 APWC01199 APWF00166 APWF00167 APWF00168 APWC01206 APWC01221 APWC01198 APWF00337 APWF00338 APWF00347 APWF00348 APWF00187 APWF00188 APWF00106 APWF00373 APWF00374 APWF00376 APWF00377 APWF00378 APWF00392 APWF00393 APWF00394 APWF00412 APWF00366 APWF00367 APWF00370 APWF00371 APWF00372 APWF00375 APWF00391 APWF00410 APWF00411 APWF00413 APWF00119 APWT00259 APWT00260 APWT00262 APWZ01081 APWE01969 APWF00113 APWF00159 APWF00160 APWF00161 APWF00162 APWF00164 APWW01662 APWE01932 APWV00241 APWV00250 APWV00264 APWF00196 APWF00139 APWF00165 APWF00345 APWE01892 APWE01893 APWE01894 APWE01896 APWE01980 APWE01981 APWF00379 APWF00236 APWE01901 APWE01913 APWE02043 APWF00508 APWF00509 APWE01982 APWE01984 APWE01985 APWE02009 APWF00201 APWC01326 APWF00205 APWF00206 APWF00365 APWE01993 APWE01975 APWE01976 APWF00415 APWF00416 APWE01979 APWE01991 APWE01992 APWY00450 APWT00103 APWF00202 APWF00203 APWF00133 APWF00261 APWF00176 APWF00175 APWF00177 APWE02063 APWF00229 APWF00142 APWF00343 APWF00344 APWF00156 APWF00158 APWF00425 APWF00428 APWF00430 APWF00426 APWF00427 APWF00429 APWF00431 APWF00115 APWF00228 APWF00137 APWF00127 APWF00128 APWF00129 APWF00130 APWF00131 APWE01978 APWE01904 APWE01917 APWS00366 APWF00199 APWF00200 APWE01953 APWE01954 APWE01955 APWE01959 APWF00273 APWF00275 APWF00276 APWF00277 APWF00278 APWE01986 APWE02067 APWF00292 APWF00293 APWE02069 APWC01061 APWC01078 APWE02006 APWF00118 APWF00314 APWF00315 APWF00215 APWF00216 APWF00217 APWF00218 APWF00219 APWF00444 APWF00445 APWF00446 APWF00447 APWF00448 APWE01899 APWE01897 APWF00116 APWF00117 APWF00408 APWE01977 APWF00125 APWF00126 APWF00185 APWF00186 APWF00124 APWF00341 APWF00342 APWF00450 APWF00451 APWF00452 APWF00453 APWF00454 APWF00455 APWF00209 APWF00210 APWF00211 APWF00212 APWF00213 APWF00384 APWF00227 APWE01872 APWF00232 APWF00443 APWF00363 APWF00364 APWF00198 APWF00108 APWF00109 APWF00110
FEI Number 2112667
Recalling Firm/
Manufacturer		 Datex-Ohmeda, Inc.
3030 Ohmeda Dr
Madison WI 53718-6704
For Additional Information ContactGE HealthCare Service
800-437-1171
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionAn URGENT MEDICAL DEVICE CORRECTION notification letter dated 7/30/26 was sent to customers. Actions to be taken by Customer/User Pending corrections from GE HealthCare, you can continue to use your Anesthesia system by following the instruction below: 1. Prior to each use, complete preoperative checkout and tests in accordance with the instructions in the User Reference Manual (URM). 2. When Alternate O2 control is enabled, the clinician should adjust the Alternate O2 flow as appropriate for the case. Use the Alternate O2 control knob to adjust the O2 flow. 3. When Alternate O2 control is enabled, flow from the electronic mixer is stopped and the agent concentration is set to off. Two situations are possible regarding the Agent quick key: a. The Agent quick key will be blank on the display if agent delivery is unavailable. Supplement with or transition to intravenous anesthetics as needed. b. The Agent quick key will be present on the display if agent delivery can be resumed. Press the Agent quick key to set the desired concentration and press the key again to confirm. 4. Please evaluate existing service stock for the Field Replaceable Unit (FRU) spare parts listed below and dispose of all affected FRU parts according to your facility procedures. Please ensure all potential staff in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached acknowledgement form electronically via FMI 34147 Digital Response Form or print, fill out manually, scan, and email to recall.34147@gehealthcare.com. Product Correction GE HealthCare will inspect and correct as necessary all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. Contact Information If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce475 units
DistributionWorldwide - US Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = BSZ
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