FDAFDA · Food and drugs·Recall number Z-0115-2020
Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-9118-000 d) 1006-9112-000 e) 1006-9113-000 f) 1006-9020-000 g) 1006-9033-000 h) 1006-9117-000 i) 1006-9119-000 j) 1006-9030-000 k) 1006-9032-000 l) 1006-9022-000 m) To be provided n) 1006-9120-000 o) 1006-9027-000 p) 1006-9003-000 q) 1006-9025-000
Published December 25, 2019 · Recall initiated: July 19, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may provide an opportunity for a malicious actor that has already penetrated the hospital network to send fraudulent flow sensor correction parameters.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- Worldwide
- Lot
- a) 1006-9300-000 Lot/Serial Numbers: AMRB00497 b) 1006-9305-000 Lot/Serial Numbers: AMRE01294 AMRF01283 AMRG01624 AMRG01625 AMRF02527 AMRF02529 AMRF02532 AMRF02534 AMRE02800 AMRE00725 AMRE01720 AMRF02386 AMRF02398 AMRF02399 AMRF02400 AMRF02401 AMRF02402 AMRF02403 AMRG02367 AMRG02368 AMRG02369 AMRG02370 AMRH00168 AMRE01962 AMRE01297 AMRE01298 AMRE01299 AMRE01300 AMRE01301 AMRE01302 AMRE01303 AMRE02061 AMRE02065 AMRE02124 AMRE01395 AMRF02556 AMRG02955 AMRG02958 AMRG03077 AMRG03179 AMRE00891 AMRE00892 AMRE00893 AMRE00894 AMRE01178 AMRE01179 AMRE01182 AMRE01183 AMRE01184 AMRE01185 AMRE01186 AMRE01187 AMRE01188 AMRE01191 AMRE01192 AMRE01193 AMRE01195 AMRE01719 AMRG00316 AMRF03164 AMRF03165 AMRF03166 AMRF03167 AMRF03168 AMRF03169 AMRF03170 AMRE01930 AMRE02795 AMRG00695 AMRG00696 AMRG00697 AMRE00911 AMRE00912 AMRF02650 AMRF02651 AMRF02652 AMRF02653 AMRE01465 AMRE01466 AMRE01659 AMRE01660 AMRE01664 AMRE01268 AMRE01336 AMRE01337 AMRE01338 AMRE02143 AMRE02648 AMRF01160 AMRF01211 AMRF01212 AMRF01213 AMRF01214 AMRF01215 AMRF02143 AMRF03161 AMRG00605 AMRG00606 AMRG00607 AMRG00608 AMRH00589 AMRH00591 AMRH00594 AMRF01298 AMRG01091 AMRG01092 AMRG01093 AMRG01094 AMRG01095 AMRG01096 AMRG01097 AMRG01098 AMRG01099 AMRG01100 AMRG01101 AMRG01102 AMRF01489 AMRE02796 AMRE02797 AMRF00684 AMRG01162 AMRF00355 AMRF00356 AMRF00357 AMRF00358 AMRF00359 AMRF00545 AMRF00548 AMRF00551 AMRF00829 AMRF00830 AMRF00831 AMRE00128 AMRF00924 AMRG01269 AMRG01249 AMRG01250 AMRG01837 AMRF00360 AMRE02935 AMRF02147 AMRE01806 AMRE01811 AMRE01812 AMRE01392 AMRE02339 AMRF01819 AMRF01322 AMRF01323 AMRF03137 AMRF03138 AMRG02943 AMRG02954 AMRE01393 AMRE01687 AMRE02687 AMRE02023 AMRE00707 AMRE00718 AMRE00719 AMRF01964 AMRF01965 AMRF01966 AMRF01967 AMRF01968 AMRG01640 AMRF00630 AMRF02893 AMRF02894 AMRG00971 AMRG00972 AMRG00973 AMRG00974 AMRE01048 AMRE01107 AMRE01259 AMRE01262 AMRE01263 AMRE02517 AMRE03018 AMRE03019 AMRE03020 AMRF00176 AMRF00177 AMRF00433 AMRF00434 AMRF00680 AMRF00681 AMRF01613 AMRF01816 AMRF01818 AMRH00592 AMRH00593 AMRE01973 AMRE02526 AMRF01969 AMRF01973 AMRG01597 AMRE01124 AMRE02356 AMRE02357 AMRE02358 AMRE02359 AMRE02360 AMRE02362 AMRG02595 AMRE00531 AMRE02026 AMRF00987 AMRE01160 AMRE02394 AMRE01111 AMRG01604 AMRG01606 AMRG01607 AMRG01610 AMRG01844 AMRH00869 AMRH00870 AMRH00871 AMRF01055 AMRE02416 AMRE02421 AMRF00137 AMRF00138 AMRF03172 AMRG00439 AMRE00850 AMRE00851 AMRE00852 AMRE00853 AMRE01109 AMRE01242 AMRE01243 AMRE01244 AMRE01257 AMRE01909 AMRE01912 AMRE02524 AMRE02529 AMRF00679 AMRF01002 AMRF01003 AMRF01004 AMRF01005 AMRF01061 AMRF01062 AMRF01621 AMRF01622 AMRF01623 AMRF01624 AMRF01625 AMRF01626 AMRF01627 AMRF01628 AMRG01364 AMRG01365 AMRG01366 AMRG01367 AMRG01368 AMRG02355 AMRE00689 AMRE00202 AMRE00207 AMRE00704 AMRE00705 AMRE00706 AMRE00726 AMRE01066 AMRE01067 AMRE01921 AMRE02388 AMRE02389 AMRE02619 AMRE02620 AMRF01946 AMRG01001 AMRG01361 AMRG01362 AMRG01363 AMRG02215 AMRE01481 AMRE01482 AMRE02177 AMRE02192 AMRE02193 AMRE02194 AMRE02195 AMRE02196 AMRE02197 AMRE02458 AMRG01279 AMRG01280 AMRE01932 AMRE01933 AMRE01934 AMRE01935 AMRE02025 AMRE02027 AMRF00426 AMRF00427 AMRF00428 AMRF00429 AMRF00430 AMRF02901 AMRF02902 AMRG02145 AMRG02146 AMRG02147 AMRG02148 AMRG02149 AMRF02137 AMRE01658 AMRF01697 AMRE01492 AMRE01493 AMRE01495 AMRE01496 AMRE02305 AMRE02307 AMRH00786 AMRH00787 AMRE02390 AMRE02304 AMRF02097 AMRF02098 AMRE02250 AMRE02050 AMRF00554 AMRF01439 AMRF01440 AMRF01441 AMRF01442 AMRF02557 AMRF02558 AMRG00525 AMRG00526 AMRG00527 AMRG00528 AMRH00862 AMRG02176 AMRH00382 AMRF02416 AMRE01695 AMRE01696 AMRE01829 AMRE02046 AMRE02074 AMRE02075 AMRE02474 AMRE02849 AMRF02096 AMRF02833 AMRF02834 AMRH00165
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.