FDA · Medical device recall

Aestiva MRI… and 3 more products

Dec. 25, 2019 Class II

Date: Dec. 25, 2019
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Terminated
Filed by: GE Healthcare, LLC
Reason: 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.
Distribution pattern: Worldwide

4 products in this recall

Aestiva MRI…

Product: Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-9310-000-015243 g) 1006-9310-000-017602 h) 1006-9310-000-103785 I) 1006-9310-000-025109 j) 1006-9310-000-009650 k) 1006-9310-000-015224 l) 1006-9310-000-031881 m) 1006-9310-000-031854 n) 1006-9310-000-026571
Quantity: 502 devices
Codes and lots: a) 1006-9310-000 Lot/Serial Numbers: AMTE00190 AMTH00218 AMTE00125 AMTE00126 AMTE00118 AMTG00102 AMTF00224 AMTG00108 b) 1006-9110-000 Lot/Serial Numbers: AMTG00211 AMTG00149 AMTF00152 AMTH00115 AMTH00172 AMTH00108 AMTF00127 AMTH00125 AMTF00128 AMTF00189 AMTH00100 AMTG00111 AMTH00210 AMTG00178 AMTG00199 AMTF00126 AMTF00153 AMTG00113 AMTH00134 AMTF00168 AMTH00114 AMTG00177 AMTF00211 AMTF00166 AMTF00197 AMTF00143 AMTG00156 AMTG00115 AMTE00221 AMTF00125 AMTG00146 AMTG00167 AMTG00179 AMTG00190 AMTH00193 AMTH00194 AMTF00167 AMTF00141 AMTH00116 AMTG00169 AMTG00159 AMTG00212 AMTG00213 AMTF00144 AMTG00112 AMTH00126 AMTG00166 AMTG00155 AMTF00165 AMTE00222 AMTF00210 AMTE00225 AMTG00197 AMTG00148 AMTH00118 AMTH00133 AMTF00142 AMTF00129 AMTH00190 AMTE00227 AMTG00147 AMTG00201 AMTG00175 AMTF00169 AMTF00212 AMTG00165 AMTF00154 AMTG00145 AMTF00203 AMTH00119 AMTF00151 AMTH00117 AMTG00168 AMTG00176 AMTF00150 AMTF00209 AMTH00186 AMTF00140 AMTF00108 AMTE00223 AMTH00132 AMTG00158 AMTH00107 AMTF00183 AMTG00114 AMTG00200 AMTG00198 c) 1006-9023-000 Lot/Serial Numbers: AMTE00239 AMTF00120 AMTE00155 AMTH00183 AMTH00144 AMTF00123 AMTF00190 AMTE00158 AMTG00136 AMTD00108 AMTD00105 AMTF00121 AMTD00122 AMTE00220 AMTE00159 AMTG00138 AMTE00157 AMTE00156 AMTF00122 AMTF00124 AMTG00137 AMTD00110 AMTF00192 AMTD00109 d) 1006-9028-000 Lot/Serial Numbers: AMTF00170 e) 1006-9310-000-305077 Lot/Serial Numbers: AMTT00236 f) 1006-9310-000-015243 Lot/Serial Numbers: AMTL00106 g) 1006-9310-000-017602 Lot/Serial Numbers: AMTR00110 AMTL00285 AMTP00299 AMTL00194 h) 1006-9310-000-103785 Lot/Serial Numbers: AMTR00120 I) 1006-9310-000-025109 Lot/Serial Numbers: AMTM00216 AMTM00196 j) 1006-9310-000-009650 Lot/Serial Numbers: AMTK00152 k) 1006-9310-000-015224 Lot/Serial Numbers: AMTL00102 l) 1006-9310-000-031881 Lot/Serial Numbers: AMTN00100 AMTN00101 m) 1006-9310-000-031854 Lot/Serial Numbers: AMTN00211 n) 1006-9310-000-026571 Lot/Serial Numbers:
Recall started: July 19, 2019
Device type: Gas-Machine, Anesthesia
Root cause (FDA): Software in the Use Environment
What the company told customers: The firm sent an urgent medical device correction notice to their consignees by letter on 07/19/2019. The letter explained the issue and requested that the consignee ensure that the devices are connected to a sufficiently secure terminal server.
Recall number: Z-0114-2020

Aestiva 7900…

Product: 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
Quantity: 7168 devices
Codes and lots: 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 AMRH00190 AMRH00191 AMRH00192 AMRH00193 AMRH00194 AMRH00195 AMRH00196 AMRH00197 AMRH00198 AMRH00199 AMRH00200 AMRH00201 AMRH00202 AMRE01443 AMRE01904 AMRE01905 AMRE01906 AMRE01907 AMRE01908 AMRH00445 AMRH00446 AMRE01813 AMRE00825 AMRE01706 AMRF02012 AMRF02013 AMRF02014 AMRF02015 AMRF01694 AMRF01695 AMRE01133 AMRE01134 AMRE01135 AMRE01713 AMRE01716 AMRE01722 AMRG00152 AMRF01486 AMRG01155 AMRE01227 AMRG02775 AMRG02776 AMRE02398 AMRE02406 AMRE02408 AMRE02411 AMRF03043 AMRF03044 AMRE01189 AMRE01190 AMRE01194 AMRE01446 AMRE02294 AMRF00809 AMRF01542 AMRF01543 AMRF01544 AMRF01545 AMRF01546 AMRF01547 AMRF01548 AMRF01549 AMRF01550 AMRF01551 AMRF01552 AMRF01553 AMRF01554 AMRF01555 AMRF01604 AMRF01605 AMRF01606 AMRF01607 AMRF01608 AMRF01609 AMRF01610 AMRF01611 AMRF03173 AMRF03174 AMRF03175 AMRG03024 AMRG01168 AMRG03298 AMRF01891 AMRF02306 AMRF02307 AMRF02308 AMRF02309 AMRF02310 AMRF02312 AMRF01314 AMRF01803 AMRF01804 AMRF01812 AMRF02976 AMRE02402 AMRE02405 AMRG02197 AMRG01995 AMRG01996 AMRF02007 AMRH00230 AMRH00231 AMRF02413 AMRF02414 AMRF02415 AMRF02417 AMRF02418 AMRG00268 AMRG00269 AMRG00271 AMRG00272 AMRG00273 AMRG02306 AMRG02307 AMRG02308 AMRE01284 AMRF01284 AMRF01285 AMRF02553 AMRE00944 AMRE00945 AMRE00946 AMRE00947 AMRE00948 AMRE00949 AMRE00950 AMRE00951 AMRG01103 AMRH00621 AMRH00622 AMRE02920 AMRF02325 AMRF03156 AMRF03157 AMRF03159 AMRF03162 AMRF03163 AMRE01624 AMRE01625 AMRF01053 AMRF01054 AMRF02628 AMRF02629 AMRF02410 AMRG02575 AMRH00847 AMRF01879 AMRF01880 AMRF01881 AMRF01974 AMRE01155 AMRE02204 AMRE02205 AMRE02206 AMRE02207 AMRE02208 AMRE02210 AMRE02222 AMRE02223 AMRE02224 AMRE02225 AMRE02226 AMRE02227 AMRE02228 AMRE02229 AMRE02230 AMRE02231 AMRE02241 AMRF02300 AMRF02302 AMRF02303 AMRF02304 AMRF02305 AMRF02680 AMRG01325 AMRG01932 AMRE02587 AMRE02589 AMRF00211 AMRF00213 AMRF00214 AMRF00215 AMRF00216 AMRF00719 AMRG00291 AMRG00292 AMRG00293 AMRG00294 AMRG00295 AMRG00296 AMRG00297 AMRG00298 AMRG00299 AMRG01151 AMRG01152 AMRG01153 AMRE01598 AMRE01626 AMRE00603 AMRE00613 AMRE00614 AMRE00631 AMRE01253 AMRE01953 AMRE02068 AMRE02916 AMRE02917 AMRE01590 AMRE01618 AMRE01830 AMRE02840 AMRE02843 AMRE02844 AMRE02852 AMRF00240 AMRF00241 AMRF00242 AMRF00244 AMRG01175 AMRG02323 AMRG02324 AMRG02472 AMRH00393 AMRH00394 AMRH00395 AMRE00628 AMRE01620 AMRF00846 AMRF01495 AMRF01496 AMRF01497 AMRE01893 AMRE01894 AMRE01895 AMRE01896 AMRE01897 AMRE01899 AMRE01900 AMRE01901 AMRE01902 AMRE01903 AMRE02417 AMRG00276 AMRG00654 AMRG00662 AMRE02950 AMRE02951 AMRE02952 AMRE02953 AMRE01387 AMRF01661 AMRF01662 AMRF01663 AMRF01664 AMRF01665 AMRF01666 AMRF01667 AMRF01668 AMRF01669 AMRF01670 AMRF01671 AMRG01378 AMRG01379 AMRG01380 AMRG02164 AMRG02165 AMRE01008 AMRE02621 AMRE02624 AMRE01948 AMRE02111 AMRE02113 AMRF01827 AMRF01841 AMRG02028 AMRH00433 AMRH00795 AMRH00797 AMRH00798 AMRH00799 AMRH00800 AMRH00801 AMRH00802 AMRF00721 AMRE02944 AMRE02945 AMRE02946 AMRE02947 AMRE02949 AMRE02891 AMRE02892 AMRF00920 AMRF00921 AMRE00682 AMRE01136 AMRE01379 AMRE01381 AMRE01383 AMRE01384 AMRE01390 AMRE01414 AMRE01421 AMRE01467 AMRE01468 AMRE01469 AMRE01470 AMRE01471 AMRE01472 AMRE01738 AMRE01739 AMRE01740 AMRF00991 AMRF00992 AMRG00619 AMRG01373 AMRG01374 AMRG01375 AMRG02597 AMRE01694 AMRE02609 AMRE02611 AMRE02612 AMRE02613 AMRE02337 AMRF00922 AMRE01596 AMRF00262 AMRE00643 AMRE00644 AMRE00645 AMRE00647 AMRE00648 AMRE00650 AMRE00651 AMRE00652 AMRE00654 AMRE01476 AMRE01477 AMRE01478 AMRE01628 AMRE01631 AMRE01689 AMRE01690 AMRE01828 AMRE02002 AMRE02014 AMRE02015 AMRE02361 AMRE02393 AMRE02395 AMRF00488 AMRF00500 AMRF00501 AMRF00514 AMRF00515 AMRF00516 AMRF01447 AMRF01448 AMRF01699 AMRF01807 AMRF01809 AMRF01820 AMRF02789 AMRG00436 AMRG00918 AMRG00919 AMRG01135 AMRG01273 AMRG01274 AMRG01579 AMRG01580 AMRG01714 AMRG02142 AMRG02143 AMRG02892 AMRG02893 AMRG02894 AMRG02895 AMRG03201 AMRG03212 AMRG03213 AMRG03214 AMRG03215 AMRH00472 AMRH00473 AMRH00474 AMRH00597 AMRE01688 AMRE01727 AMRF02334 AMRF02335 AMRF03224 AMRG02512 AMRE00830 AMRF02345 AMRF02011 AMRF02411 AMRG02511 AMRE02084 AMRF00232 AMRE01852 AMRE02350 AMRE02385 AMRE02777 AMRE02778 AMRF01784 AMRF02332 AMRF02348 AMRF02350 AMRF02384 AMRG02357 AMRG00698 AMRG00700 AMRG00669 AMRE00536 AMRG00508 AMRG00509 AMRG00510 AMRG00511 AMRG01335 AMRG01336 AMRG01337 AMRG01338 AMRG01339 AMRH00668 AMRF00489 AMRE00988 AMRE00993 AMRE01130 AMRE01131 AMRE01132 AMRE01532 AMRE01533 AMRE01542 AMRE01543 AMRE01544 AMRE01545 AMRF00978 AMRF00980 AMRF00981 AMRF01851 AMRF01852 AMRF01853 AMRF01854 AMRE01167 AMRF02627 AMRE01918 AMRG02037 AMRE02527 AMRF02524 AMRG01156 AMRE02269 AMRE02270 AMRE02271 AMRF03059 AMRF03060 AMRH00385 AMRH00386 AMRH00387 AMRG01869 AMRG00641 AMRG00642 AMRG00643 AMRE00751 AMRE00752 AMRE00753 AMRE00802 AMRE01334 AMRE01335 AMRE01341 AMRH00389 AMRH00390 AMRH00391 AMRH00392 AMRE01168 AMRF00165 AMRF00166 AMRF00167 AMRF00168 AMRH00670 AMRH00946 AMRH00947 AMRE00804 AMRE01342 AMRE01787 AMRF03149 AMRF03150 AMRF01383 AMRF03200 AMRH00242 AMRF01954 AMRF01955 AMRF01956 AMRF01958 AMRG02162 AMRH00662 AMRE02618 AMRG01871 AMRG02782 AMRH00863 AMRH00912 AMRG01929 AMRG01930 AMRG01991 AMRG01992 AMRG01993 AMRG01994 AMRE01577 AMRE02779 AMRE01714 AMRE00758 AMRE00759 AMRE01158 AMRE01397 AMRE01814 AMRE02363 AMRE02400 AMRE02403 AMRE02404 AMRE02407 AMRE02409 AMRF01297 AMRF01299 AMRF01301 AMRF01416 AMRF01476 AMRF01805 AMRF01806 AMRF02042 AMRG00302 AMRG00382 AMRG00384 AMRG00386 AMRG02290 AMRG02291 AMRH00323 AMRH00324 AMRH00325 AMRH00326 AMRH00327 AMRH00381 AMRH00541 AMRE02085 AMRE02086 AMRE02134 AMRF01413 AMRF01415 AMRG00590 AMRG00591 AMRG00592 AMRG03193 AMRG03194 AMRE02477 AMRF00905 AMRG00303 AMRG00314 AMRG00315 AMRH00143 AMRF01354 AMRG02322 AMRE02928 AMRF01474 AMRF02793 AMRF00207 AMRF02781 AMRF02782 AMRF02783 AMRF02784 AMRF02785 AMRF02786 AMRF02787 AMRF02790 AMRF02791 AMRG00515 AMRG00516 AMRG00517 AMRG02356 AMRG02619 AMRE02816 AMRE02818 AMRF02792 AMRE00847 AMRG02152 AMRG02153 AMRF00282 AMRF00283 AMRF02330 AMRF02333 AMRG03057 AMRG03058 AMRG03059 AMRG03060 AMRH00598 AMRH00599 AMRH00600 AMRH00601 AMRH00602 AMRH00603 AMRF01302 AMRF02122 AMRF02776 AMRG03175 AMRG03176 AMRG03177 AMRE02280 AMRE02281 AMRE02282 AMRE02283 AMRE02285 AMRE02286 AMRE02287 AMRE02288 AMRE02289 AMRE02293 AMRG00928 AMRG01870 AMRG03117 AMRG03118 AMRG03119 AMRG03120 AMRG03121 AMRG03122 AMRG03123 AMRG03124 AMRG03125 AMRG03126 AMRG03127 AMRG03128 AMRG03140 AMRG03141 AMRG03142 AMRG03143 AMRG03144 AMRG03145 AMRG03146 AMRG03147 AMRG03148 AMRG03149 AMRG03150 AMRG03151 AMRG03152 AMRG03153 AMRG03159 AMRG03160 AMRG03161 AMRG03162 AMRG03163 AMRG03164 AMRG03165 AMRG03166 AMRG03167 AMRG03168 AMRG03169 AMRG03170 AMRE01881 AMRE01884 AMRE02925 AMRE02932 AMRF00169 AMRF00170 AMRF00171 AMRF00173 AMRG01804 AMRG01805 AMRG01806 AMRG01807 AMRE02645 AMRE02649 AMRG03172 AMRG03173 AMRG01681 AMRG01797 AMRE00720 AMRF00172 AMRF00174 AMRF00175 AMRE00308 AMRF00817 AMRF01292 AMRF01293 AMRF01296 AMRF02996 AMRF02997 AMRF02998 AMRG01615 AMRH00500 AMRH00501 AMRH00502 AMRH00729 AMRH00730 AMRH00731 AMRE02776 AMRE00310 AMRE00311 AMRG00955 AMRG00956 AMRG01845 AMRG02579 AMRG02580 AMRG02581 AMRG02582 AMRG02583 AMRG02584 AMRG02585 AMRG02586 AMRG02587 AMRF02420 AMRF02421 AMRE00848 AMRG03174 AMRH00669 AMRE00630 AMRE01137 AMRE01175 AMRE01951 AMRE02013 AMRE01331 AMRF02578 AMRF02581 AMRH00538 AMRF00807 AMRF01163 AMRG01935 AMRE02336 AMRE02413 AMRF01445 AMRF01446 AMRE02364 AMRF00687 AMRF00688 AMRF00783 AMRF01006 AMRF01007 AMRF01008 AMRF01009 AMRF01010 AMRF01011 AMRF01012 AMRF01048 AMRF01049 AMRE01367 AMRE01368 AMRE01927 AMRE01928 AMRE01929 AMRF00502 AMRF00503 AMRF00504 AMRF00505 AMRF01257 AMRF02127 AMRF02128 AMRF02129 AMRF02130 AMRF02131 AMRF02132 AMRF02133 AMRF02134 AMRG01487 AMRG01488 AMRH00170 AMRH00181 AMRF00932 AMRE00864 AMRE01412 AMRG03180 AMRG03181 AMRG03182 AMRG03183 AMRG03184 AMRG03185 AMRF02109 AMRH00308 AMRF02673 AMRF02676 AMRG03199 AMRF01723 AMRF01724 AMRF01725 AMRF01726 AMRF01747 AMRG02001 AMRG02714 AMRF00361 AMRG01656 AMRG02688 AMRG02712 AMRG02713 AMRG02740 AMRF02142 AMRG02320 AMRG02709 AMRG02330 AMRG02331 AMRH00691 AMRH00692 AMRH00693 AMRG00154 AMRG00155 AMRG00156 AMRG00157 AMRE01461 AMRF02139 AMRH00158 AMRH00243 AMRH00244 AMRF00298 AMRF00299 AMRF00302 AMRF00303 AMRF00304 AMRF00305 AMRF00306 AMRF00307 AMRF00308 AMRF00317 AMRF00318 AMRF00319 AMRF00320 AMRF00326 AMRF00327 AMRF00328 AMRF00329 AMRG01251 AMRE00699 AMRE00716 AMRE00722 AMRE00727 AMRE01042 AMRG02430 AMRE01247 AMRH00534 AMRE02066 AMRG01000 AMRE01125 AMRE02933…
Recall started: July 19, 2019
Device type: Ventilator, Continuous, Facility Use
Root cause (FDA): Software in the Use Environment
What the company told customers: The firm sent an urgent medical device correction notice to their consignees by letter on 07/19/2019. The letter explained the issue and requested that the consignee ensure that the devices are connected to a sufficiently secure terminal server.
Recall number: Z-0115-2020

Aespire 7100…

Product: Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. 1009-9000-000-013913 4. 1009-9000-000-001366 5. 1009-9000-000-009857 6. 1009-9003-000 7. 1009-9000-000-008120 8. 1009-9000-000-009600 9. 1009-9000-000-014290 10. 1009-9000-000-010585 11. 1009-9000-000-004993 12. 1009-9011-000-004795 13. 1009-9000-000-013407 14. 1009-9000-000-004604 15. 1009-9000-000-017674 16. 1009-9000-000-008763 17. 1009-9000-000-008306 18. 1009-9000-000-003277 19. 1009-9000-000-004166 20. 1009-9000-000-008560 21. 1009-9000-000-000299 22. 1009-9000-000-011444 23. 1009-9000-000-003529 24. 1009-9000-000-005666 25. 1009-9000-000-019821 26. 1009-9011-000 27. 1009-9000-000-017345 28. 1009-9000-000-009893 29. 1009-9000-000-007258 30. 1009-9000-000-004959 31. 1009-9000-000-010185 32. 1009-9000-000-016672 33. 1009-9011-000-017769 34. 1009-9000-000-014329 35. 1009-9011-000-020685 36. 1009-9000-000-026022 37. 1009-9011-000-002912 38. 1009-9000-000-014723 39. 1009-9000-000-013385 40. 1009-9000-000-006725 41. 1009-9000-000-005163 42. 1009-9000-000-004022 43. 1009-9000-000-017939 44. 1009-9000-000-000300 45. 1009-9000-000-018855 46. 1009-9000-000-016724 47. 1009-9000-000-010268 48. 1009-9000-000-011595 49. 1009-9000-000-019277 50. 1009-9011-000-023222 51. 1009-9011-000-015929 52. 1009-9000-000-017824 53. 1009-9000-000-008270 54. 1009-9000-000-010416 55. 1009-9000-000-019089 56. 1009-9000-000-013395 57. 1009-9011-000-021989 58. 1009-9000-000-000517 59. 1009-9000-000-002407 60. 1009-9000-000-008415 61. 1009-9000-000-009597 62. 1009-9000-000-010178 63. 1009-9011-000-010400 64. 1009-9011-000-011366 65. 1009-9000-000-012360 66. 1009-9101-000 67. 1009-9000-000-013787 68. 1009-9000-000-006266 69. 1009-9000-000-014915 70. 1009-9000-000-000290 71. 1009-9000-000-013507 72. 1009-9000-000-011600 73. 1009-9000-000-010595 74. 1009-9000-000-009543 75. 1009-9000-000-011111 76. 1009-9000-000-013378 77. 1009-9000-000-000526 78. 1009-9000-000-010536 79. 1009-9000-000-010116 80. 1009-9000-000-005939 81. 1009-9000-000-008216 82. 1009-9000-000-006786 83. 1009-9000-000-012155 84. 1009-9000-000-012379 85. 1009-9000-000-014000 86. 1009-9011-000-022466 87. 1009-9000-000-009912 88. 1009-9000-000-006906 89. 1009-9000-000-004380 90. 1009-9000-000-010245 91. 1009-9000-000-010413 92. 1009-9000-000-013616 93. 1009-9000-000-009428 94. 1009-9000-000-010597 95. 1009-9000-000-020606 96. 1009-9000-000-010059 97. 1009-9000-000-014122 98. 1009-9000-000-016795 99. 1009-9000-000-012149 100. 1009-9000-000-005760 101. 1009-9000-000-009836 102. 1009-9000-000-016818 103. 1009-9000-000-017699 104. 1009-9000-000-004020 105. 1009-9000-000-013953 106. 1009-9000-000-009583 107. 1009-9000-000-007938 108. 1009-9000-000-007336 109. 1009-9000-000-010435 110. 1009-9011-000-016719 111. 1009-9000-000-024098 112. 1009-9011-000-004634 113. 1009-9011-000-016794 114. 1009-9011-000-005431 115. 1009-9000-000-000598 116. 1009-9011-000-005442 117. 1009-9000-000-022792 118. 1009-9000-000-003950 119. 1009-9000-000-013921 120. 1009-9000-000-011116 121. 1009-9000-000-017203 122. 1009-9000-000-003335 123. 1009-9000-000-008264 124. 1009-9000-000-009868 125. 1009-9011-000-015245 truncated text
Quantity: 19351 devices
Codes and lots: Model, Catalogue or Code # Mfg. Lot or Serial # 1006-9012-000 AMVE00253 1006-9012-000 AMVF00911 1006-9012-000 AMVE00255 1006-9012-000 AMVF00605 1006-9012-000 AMVF00718 1006-9012-000 AMVF00920 1006-9012-000 AMVG00384 1006-9012-000 AMVE00252 1006-9012-000 AMVE00297 1006-9012-000 AMVF00373 1006-9012-000 AMVF00604 1006-9012-000 AMVF00677 1006-9012-000 AMVF00796 1006-9012-000 AMVF00797 1006-9012-000 AMVF01008 1006-9012-000 AMVE00298 1006-9012-000 AMVE00358 1006-9012-000 AMVE00322 1006-9012-000 AMVE00258 1006-9012-000 AMVE00259 1006-9012-000 AMVE00280 1006-9012-000 AMVE00281 1006-9012-000 AMVE00299 1006-9012-000 AMVH00464 1006-9012-000 AMVE00254 1006-9012-000 AMVE00256 1006-9012-000 AMVE00257 1006-9012-000 AMVE00324 1006-9012-000 AMVE00325 1006-9012-000 AMVG00363 1006-9012-000 AMVE00300 1006-9012-000 AMVF00361 1006-9012-000 AMVF00798 1006-9012-000 AMVF00921 1006-9012-000 AMVG00627 1006-9021-000 AMVH00192 1006-9021-000 AMVD00112 1006-9021-000 AMVD00113 1006-9021-000 AMVD00114 1006-9021-000 AMVE00135 1006-9021-000 AMVE00150 1006-9021-000 AMVG00385 1006-9021-000 AMVF00914 1006-9021-000 AMVG00386 1006-9021-000 AMVE00152 1006-9021-000 AMVF00457 1006-9021-000 AMVD00117 1006-9021-000 AMVG00466 1006-9021-000 AMVH00150 1006-9021-000 AMVH00199 1006-9021-000 AMVH00194 1006-9021-000 AMVD00111 1006-9021-000 AMVE00151 1006-9021-000 AMVH00193 1006-9021-000 AMVD00128 1006-9021-000 AMVF00676 1006-9021-000 AMVE00204 1006-9021-000 AMVE00323 1006-9021-000 AMVG00559 1006-9021-000 AMVH00149 1006-9021-000 AMVD00126 1006-9021-000 AMVH00191 1006-9024-000 AMVD00115 1006-9024-000 AMVE00220 1006-9026-000 AMVE00551 1006-9026-000 AMVF00992 1006-9026-000 AMVF01276 1006-9031-000 AMVE00203 1006-9031-000 AMVE00321 1006-9111-000 AMVF01237 1006-9111-000 AMVF01264 1006-9111-000 AMVF01265 1006-9111-000 AMVG00232 1006-9111-000 AMVF01189 1006-9111-000 AMVF01487 1006-9111-000 AMVG00626 1006-9111-000 AMVG00153 1006-9111-000 AMVF01578 1006-9111-000 AMVF01579 1006-9111-000 AMVG00233 1006-9111-000 AMVG00234 1006-9111-000 AMVF01582 1006-9111-000 AMVG00249 1006-9111-000 AMVG00250 1006-9111-000 AMVG00251 1006-9111-000 AMVG00252 1006-9111-000 AMVG00253 1006-9111-000 AMVF01166 1006-9111-000 AMVF01191 1006-9111-000 AMVG00967 1006-9111-000 AMVG00968 1006-9111-000 AMVG00821 1006-9111-000 AMVE01000 1006-9111-000 AMVG00778 1006-9111-000 AMVG00623 1006-9111-000 AMVG00969 1006-9111-000 AMVG01049 1006-9111-000 AMVG00151 1006-9111-000 AMVF00909 1006-9111-000 AMVF00910 1006-9111-000 AMVF01465 1006-9111-000 AMVF01186 1006-9111-000 AMVE00618 1006-9111-000 AMVE00619 1006-9111-000 AMVE00620 1006-9111-000 AMVE00621 1006-9111-000 AMVF01187 1006-9111-000 AMVF01188 1006-9111-000 AMVE00919 1006-9111-000 AMVE00920 1006-9111-000 AMVG00966 1006-9111-000 AMVF01167 1006-9111-000 AMVF01390 1006-9111-000 AMVG00736 1006-9111-000 AMVG00624 1006-9111-000 AMVF00599 1006-9111-000 AMVG00891 1006-9111-000 AMVF01580 1006-9111-000 AMVF00827 1006-9111-000 AMVF00828 1006-9111-000 AMVF00602 1006-9111-000 AMVF00824 1006-9111-000 AMVF01393 1006-9111-000 AMVF00148 1006-9111-000 AMVG00235 1006-9111-000 AMVG00781 1006-9111-000 AMVG00260 1006-9111-000 AMVG00261 1006-9111-000 AMVG00262 1006-9111-000 AMVG00620 1006-9111-000 AMVG00621 1006-9111-000 AMVG00258 1006-9111-000 AMVF00825 1006-9111-000 AMVF00826 1006-9111-000 AMVF01581 1006-9111-000 AMVF00906 1006-9111-000 AMVF00907 1006-9111-000 AMVF00597 1006-9111-000 AMVF00918 1006-9111-000 AMVF00919 1006-9111-000 AMVF01052 1006-9111-000 AMVF01053 1006-9111-000 AMVF01054 1006-9111-000 AMVF01055 1006-9111-000 AMVF01056 1006-9111-000 AMVF01057 1006-9111-000 AMVF01058 1006-9111-000 AMVG00779 1006-9111-000 AMVG00780 1006-9111-000 AMVG00818 1006-9111-000 AMVG00819 1006-9111-000 AMVG00820 1006-9111-000 AMVF00915 1006-9111-000 AMVF01658 1006-9111-000 AMVF01659 1006-9111-000 AMVF01323 1006-9111-000 AMVF01324 1006-9111-000 AMVG00256 1006-9111-000 AMVG00257 1006-9111-000 AMVF00145 1006-9111-000 AMVG00150 1006-9111-000 AMVG00152 1006-9111-000 AMVF00147 1006-9111-000 AMVF00600 1006-9111-000 AMVG01050 1006-9111-000 AMVF00912 1006-9111-000 AMVF01657 1006-9111-000 AMVE00983 1006-9111-000 AMVE00984 1006-9111-000 AMVF01190 1006-9111-000 AMVG00777 1006-9111-000 AMVG00907 1006-9111-000 AMVG00908 1006-9111-000 AMVG00909 1006-9111-000 AMVF01462 1006-9111-000 AMVG00110 1006-9111-000 AMVG00149 1006-9111-000 AMVG00248 1006-9111-000 AMVG00960 1006-9111-000 AMVF00598 1006-9111-000 AMVF01463 1006-9111-000 AMVG00259 1006-9111-000 AMVF00149 1006-9111-000 AMVF00593 1006-9111-000 AMVG00387 1006-9111-000 AMVG00388 1006-9111-000 AMVG00389 1006-9111-000 AMVF01115 1006-9111-000 AMVE00967 1006-9111-000 AMVG00625 1006-9111-000 AMVF00596 1006-9111-000 AMVF00595 1006-9111-000 AMVE00977 1006-9111-000 AMVG00228 1006-9111-000 AMVG00229 1006-9111-000 AMVG00230 1006-9111-000 AMVG00231 1006-9111-000 AMVG00226 1006-9111-000 AMVG00227 1006-9111-000 AMVG00622 1006-9111-000 AMVF00146 1006-9111-000 AMVE01002 1006-9111-000 AMVF00594 1006-9111-000 AMVF00601 1006-9111-000 AMVF00917 1006-9111-000 AMVF00908 1006-9111-000 AMVF01059 1006-9111-000 AMVG00255 1006-9111-000 AMVF00916 1006-9111-000 AMVG01026 1006-9111-000 AMVG01027 1006-9111-000 AMVG01028 1006-9111-000 AMVF01322 1006-9111-000 AMVG00254 1006-9111-000 AMVF01446 1006-9111-000 AMVG00154 1006-9111-000 AMVE01001 1006-9111-000 AMVF01391 1006-9111-000 AMVF01392 1006-9111-000 AMVF01464 1006-9114-000 AMVF00190 1006-9114-000 AMVF00191 1006-9114-000 AMVF00603 1006-9320-000 AMVF01305 1006-9320-000 AMVF00551 1006-9320-000 AMVF00552 1006-9320-000 AMVF00606 1006-9320-000 AMVF00607 1006-9320-000 AMVJ00125 1006-9320-000 AMVF01663 1006-9320-000 AMVE00114 1006-9320-000 AMVF00735 1006-9320-000 AMVH00136 1006-9320-000 AMVF01346 1006-9320-000 AMVG00631 1006-9320-000 AMVG00904 1006-9320-000 AMVG01053 1006-9320-000 AMVH00272 1006-9320-000 AMVH00366 1006-9320-000 AMVE00308 1006-9320-000 AMVF00523 1006-9320-000 AMVF00524 1006-9320-000 AMVF00525 1006-9320-000 AMVF00526 1006-9320-000 AMVF00527 1006-9320-000 AMVF00528 1006-9320-000 AMVF01363 1006-9320-000 AMVH00271 1006-9320-000 AMVE00445 1006-9320-000 AMVE00372 1006-9320-000 AMVE00732 1006-9320-000 AMVE00733 1006-9320-000 AMVE00734 1006-9320-000 AMVE00767 1006-9320-000 AMVE00879 1006-9320-000 AMVE00881 1006-9320-000 AMVE00882 1006-9320-000 AMVF01353 1006-9320-000 AMVF01051 1006-9320-000 AMVH00821 1006-9320-000 AMVE00433 1006-9320-000 AMVE00891 1006-9320-000 AMVE00899 1006-9320-000 AMVF00276 1006-9320-000 AMVF00786 1006-9320-000 AMVF01572 1006-9320-000 AMVF01573 1006-9320-000 AMVF01575 1006-9320-000 AMVF01576 1006-9320-000 AMVF01577 1006-9320-000 AMVF01643 1006-9320-000 AMVF01644 1006-9320-000 AMVF01645 1006-9320-000 AMVG00812 1006-9320-000 AMVH00533 1006-9320-000 AMVH00837 1006-9320-000 AMVH00838 1006-9320-000 AMVH00839 1006-9320-000 AMVH00840 1006-9320-000 AMVH00841 1006-9320-000 AMVH00842 1006-9320-000 AMVH00843 1006-9320-000 AMVF01049 1006-9320-000 AMVJ00212 1006-9320-000 AMVE00465 1006-9320-000 AMVE00466 1006-9320-000 AMVE00467 1006-9320-000 AMVE00468 1006-9320-000 AMVE00482 1006-9320-000 AMVE00729 1006-9320-000 AMVE00730 1006-9320-000 AMVE00480 1006-9320-000 AMVE00483 1006-9320-000 AMVE00576 1006-9320-000 AMVE00577 1006-9320-000 AMVF00891 1006-9320-000 AMVF00892 1006-9320-000 AMVF00895 1006-9320-000 AMVG00341 1006-9320-000 AMVF01555 1006-9320-000 AMVF01556 1006-9320-000 AMVJ00106 1006-9320-000 AMVJ00214 1006-9320-000 AMVJ00215 1006-9320-000 AMVE00864 1006-9320-000 AMVE00435 1006-9320-000 AMVH00791 1006-9320-000 AMVG00158 1006-9320-000 AMVG00562 1006-9320-000 AMVG00563 1006-9320-000 AMVG00564 1006-9320-000 AMVH00541 1006-9320-000 AMVH00542 1006-9320-000 AMVJ00154 1006-9320-000 AMVJ00158 1006-9320-000 AMVH00536 1006-9320-000 AMVE00662 1006-9320-000 AMVD00125 1006-9320-000 AMVF01145 1006-9320-000 AMVF01146 1006-9320-000 AMVF01147 1006-9320-000 AMVF01148 1006-9320-000 AMVF01150 1006-9320-000 AMVF01151 1006-9320-000 AMVF01152 1006-9320-000 AMVH00302 1006-9320-000 AMVH00137 1006-9320-000 AMVH00725 1006-9320-000 AMVG00567 1006-9320-000 AMVE00942 1006-9320-000 AMVE00943 1006-9320-000 AMVE00944 1006-9320-000 AMVE00945 1006-9320-000 AMVE00946 1006-9320-000 AMVE00947 1006-9320-000 AMVG00876 1006-9320-000 AMVG00902 1006-9320-000 AMVG00903 1006-9320-000 AMVE00487 1006-9320-000 AMVH00726 1006-9320-000 AMVH00727 1006-9320-000 AMVH00728 1006-9320-000 AMVH00908 1006-9320-000 AMVF00125 1006-9320-000 AMVF00529 1006-9320-000 AMVG00543 1006-9320-000 AMVJ00133 1006-9320-000 AMVJ00134 1006-9320-000 AMVF01161 1006-9320-000 AMVF01162 1006-9320-000 AMVF01163 1006-9320-000 AMVF01164 1006-9320-000 AMVF01165 1006-9320-000 AMVF01254 1006-9320-000 AMVF01255 1006-9320-000 AMVF01256 1006-9320-000 AMVH00360 1006-9320-000 AMVH00361 1006-9320-000 AMVH00503 1006-9320-000 AMVJ00178 1006-9320-000 AMVJ00179 1006-9320-000 AMVH00902 1006-9320-000 AMVF00710 1006-9320-000 AMVF00723 1006-9320-000 AMVF00724 1006-9320-000 AMVG00842 1006-9320-000 AMVG00794 1006-9320-000 AMVE00706 1006-9320-000 AMVF00477 1006-9320-000 AMVH00729 1006-9320-000 AMVH00730 1006-9320-000 AMVH00731 1006-9320-000 AMVH00732 1006-9320-000 AMVE00406 1006-9320-000 AMVH00333 1006-9320-000 AMVH00579 1006-9320-000 AMVG00715 1006-9320-000 AMVF01427 1006-9320-000 AMVF01355 1006-9320-000 AMVF01356 1006-9320-000 AMVF01358 1006-9320-000 AMVG01057 1006-9320-000 AMVG01058 1006-9320-000 AMVG01059 1006-9320-000 AMVG01060 1006-9320-000 AMVG00342 1006-9320-000 AMVG00343 1006-9320-000 AMVG00344 1006-9320-000 AMVG00345 1006-9320-000 AMVG00346 1006-9320-000 AMVF01429 1006-9320-000 AMVF01430 1006-9320-000 AMVF01431 1006-9320-000 AMVE00222 1006-9320-000 AMVJ00128 1006-9320-000 AMVF00734 1006-9320-000 AMVF00787 1006-9320-000 AMVF00788 1006-9320-000 AMVF01364 1006-9320-000 AMVF01416 1006-9320-000 AMVF01417 1006-9320-000 AMVF01418 1006-9320-000 AMVF01470 1006-9320-000 AMVG00139 1006-9320-000 AMVG00853 1006-9320-000 AMVG00854 1006-9320-000 AMVG00855 1006-9320-000 AMVE00319 1006-9320-000 AMVE00320 1006-9320-000 AMVF00712 1006-9320-000 AMVF00713 1006-9320-000 AMVF00714 1006-9320-000 AMVF00715 1006-9320-000 AMVF00716 1006-9320-000 AMVF00717 1006-9320-000 AMVF00883 1006-9320-000 AMVJ00219 1006-9320-000 AMVF00129 1006-9320-000 AMVG00338 1006-9320-000 AMVE00444 1006-9320-000 AMVH00228 1006-9320-000 AMVJ00152 1006-9320-000 AMVJ00155 1006-9320-000 AMVJ00156 1006-9320-000 AMVE00938 1006-9320-000 AMVG00713 1006-9320-000 AMVG00714 1006-9320-000 AMVG00719 1006-9320-000 AMVE00356 1006-9320-000 AMVE00357 1006-9320-000 AMVE00369 1006-9320-000 AMVE00370 1006-9320-000 AMVE00371 1006-9320-000 AMVE00373 1006-9320-000 AMVH00723 1006-9320-000 AMVH00724 1006-9320-000 AMVG00440 1006-9320-000 AMVG00140 1006-9320-000 AMVH00472 1006-9320-000 AMVH00478 1006-9320-000 AMVH00789 1006-9320-000 AMVE00478 1006-9320-000 AMVE00481 1006-9320-000 AMVF00722 1006-9320-000 AMVE00960 1006-9320-000 AMVE00962 1006-9320-000 AMVF00277 1006-9320-000 AMVF01050 1006-9320-000 AMVH00214 1006-9320-000 AMVE00476 1006-9320-000 AMVE00477 1006-9320-000 AMVE00479 1006-9320-000 AMVH00875 1006-9320-000 AMVF00890 1006-9320-000 AMVF00893 1006-9320-000 AMVF00896 1006-9320-000 AMVG00712 1006-9320-000 AMVE00714 1006-9320-000 AMVF00779 1006-9320-000 AMVF00780 1006-9320-000 AMVF00781 1006-9320-000 AMVF00782 1006-9320-000 AMVF00783 1006-9320-000 AMVF00784 1006-9320-000 AMVG00566 1006-9320-000 AMVG00856 1006-9320-000 AMVH00134 1006-9320-000 AMVH00135 1006-9320-000 AMVH00667 1006-9320-000 AMVH00668 1006-9320-000 AMVH00669 1006-9320-000 AMVH00903 1006-9320-000 AMVH00904 1006-9320-000 AMVH00905 1006-9320-000 AMVH00528 1006-9320-000 AMVH00529 1006-9320-000 AMVH00459 1006-9320-000 AMVE00383 1006-9320-000 AMVH00327 1006-9320-000 AMVH00328 1006-9320-000 AMVH00329 1006-9320-000 AMVD00164 1006-9320-000 AMVF01042 1006-9320-000 AMVF01043 1006-9320-000 AMVF01044 1006-9320-000 AMVF01045 1006-9320-000 AMVF01046 1006-9320-000 AMVF01047 1006-9320-000 AMVF01048 1006-9320-000 AMVG00242 1006-9320-000 AMVG00243 1006-9320-000 AMVH00769 1006-9320-000 AMVH00770 1006-9320-000 AMVJ00169 1006-9320-000 AMVF00894 1006-9320-000 AMVH00132 1006-9320-000 AMVH00133 1006-9320-000 AMVE00880…
Recall started: July 19, 2019
Device type: Gas-Machine, Anesthesia
Root cause (FDA): Software in the Use Environment
What the company told customers: The firm sent an urgent medical device correction notice to their consignees by letter on 07/19/2019. The letter explained the issue and requested that the consignee ensure that the devices are connected to a sufficiently secure terminal server.
Recall number: Z-0116-2020

Aestiva 7100…

Product: Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-9320-000-001101 4. 1006-9021-000 5. 1006-9012-000 6. 1006-9111-000 7. 1006-9321-000-007639 8. 1006-9321-000-000023 9. 1006-9321-000-015180 10. 1006-9320-000-010369 11. 1006-9321-000-019486 12. 1006-9321-000-007601 13. 1006-9321-000-009266 14. 1006-9321-000-008526 15. 1006-9321-000-116507 16. 1006-9321-000-009244 17. 1006-9321-000-012769 18. 1006-9320-000-004497 19. 1006-9320-000-009697 20. 1006-9320-000-014484 21. 1006-9321-000-008072 22. 1006-9321-000-007618 23. 1006-9321-000-013784 24. 1006-9320-000-010963 25. 1006-9320-000-014485 26. 1006-9320-000-008839 27. 1006-9321-000-017374 28. 1006-9321-000-014553 29. 1006-9031-000 30. 1006-9321-000-000533 31. 1006-9321-000-007785 32. 1006-9320-000-016418 33. 1006-9320-000-013302 34. 1006-9320-000-020339 35. 1006-9320-000-002141 36. 1006-9320-000-009193 37. 1006-9320-000-014443 38. 1006-9320-000-008124 39. 1006-9321-000-009347 40. 1006-9320-000-009310 41. 1006-9320-000-004623 42. 1006-9321-000-020437 43. 1006-9321-000-025830 44. 1006-9321-000-004690 45. 1006-9321-000-011348 46. 1006-9114-000 47. 1006-9322-000 48. 1006-9321-000-006678 49. 1006-9321-000-043401 50. 1006-9322-000-043399 51. 1006-9320-000-018778 52. 1006-9320-000-010161 53. 1006-9320-000-009400 54. 1006-9320-000-007948 55. 1006-9321-000-001309 56. 1006-9321-000-008305 57. 1006-9321-000-027472 58. 1006-9321-000-008643 59. 1006-9320-000-008841 60. 1006-9320-000-010102 61. 1006-9322-000-020407 62. 1006-9321-000-004831 63. 1006-9320-000-010684 64. 1006-9320-000-014654 65. 1006-9320-000-006392 66. 1006-9320-000-009056 67. 1006-9321-000-025850 68. 1006-9320-000-000473 69. 1006-9320-000-017639 70. 1006-9321-000-003110 71. 1006-9321-000-019653 72. 1006-9321-000-008529 73. 1006-9321-000-010029 74. 1006-9321-000-005790 75. 1006-9320-000-010177 76. 1006-9320-000-028131 77. 1006-9321-000-006318 78. 1006-9322-000-106884 79. 1006-9320-000-004596 80. 1006-9321-000-006645 81. 1006-9321-000-010584 82. 1006-9320-000-007779 83. 1006-9320-000-025679 84. 1006-9320-000-011509 85. 1006-9320-000-008650 86. 1006-9321-000-020045 87. 1006-9321-000-014996 88. 1006-9320-000-015449 89. 1006-9320-000-010685 90. 1006-9321-000-000266 91. 1006-9321-000-019680 92. 1006-9321-000-004778 93. 1006-9321-000-004424 94. 1006-9321-000-008747 95. 1006-9320-000-009249 96. 1006-9320-000-010834 97. 1006-9320-000-022596 98. 1006-9024-000 99. 1006-9026-000 100. 1006-9322-000-011934 101. 1006-9322-000-049412 102. 1006-9322-000-110551 103. 1006-9320-000-019424 104. 1006-9321-000-017187 105. 1006-9321-000-005997 106. 1006-9321-000-091883 107. 1006-9321-000-004524 108. 1006-9321-000-013425 109. 1006-9320-000-015413 110. 1006-9321-000-007378 111. 1006-9320-000-010661 112. 1006-9321-000-005998 113. 1006-9321-000-156642 114. 1006-9320-000-015195 115. 1006-9320-000-017086 116. 1006-9320-000-017852 117. 1006-9321-000-001974 118. 1006-9321-000-010236 119. 1006-9321-000-007641 120. 1006-9321-000-014028 121. 1006-9321-000-015552 122. 1006-9321-000-011524 123. 1006-9321-000-009297 124. 1006-9320-000-017427 125. 1006-9320-000-017498 126. 1006-9321-000-022470 127. 1006-9321-000-024751 128. 1006-9321-000-007642 129. 1006-9321-000-007636 130. 1006-9321-000-029968 131. 1006-9321-000-039161 132. 1006-9321-000-035978 133. 1006-9321-000-011702 134. 1006-9321-000-043612 models truncated
Quantity: 473 devices
Codes and lots: Model, Catalogue or Code # Mfg. Lot or Serial # 1006-9012-000 AMVE00253 1006-9021-000 AMVH00192 1006-9024-000 AMVD00115 1006-9026-000 AMVE00551 1006-9031-000 AMVE00203 1006-9111-000 AMVF01237 1006-9114-000 AMVF00190 1006-9320-000 AMVF01305 1006-9320-000-000001 AMVJ00223 1006-9320-000-000473 AMVH00771 1006-9320-000-000581 AMVJ00239 1006-9320-000-000607 AMVJ00235 1006-9320-000-001101 AMVH00772 1006-9320-000-001211 AMVJ00264 1006-9320-000-002141 AMVJ00336 1006-9320-000-002316 AMVJ00344 1006-9320-000-002368 AMVH00778 1006-9320-000-002450 AMVJ00254 1006-9320-000-002634 AMVH00774 1006-9320-000-003359 AMVJ00316 1006-9320-000-003863 AMVJ00378 1006-9320-000-004311 AMVJ00374 1006-9320-000-004497 AMVJ00408 1006-9320-000-004596 AMVJ00822 1006-9320-000-004623 AMVK00526 1006-9320-000-005394 AMVJ00460 1006-9320-000-005531 AMVJ00486 1006-9320-000-005677 AMVJ00462 1006-9320-000-005868 AMVH00777 1006-9320-000-006392 AMVJ00489 1006-9320-000-006773 AMVK00203 1006-9320-000-006850 AMVJ00537 1006-9320-000-007245 AMVJ00569 1006-9320-000-007380 AMVJ00575 1006-9320-000-007617 AMVJ00576 1006-9320-000-007779 AMVK00110 1006-9320-000-007948 AMVK00137 1006-9320-000-007961 AMVK00169 1006-9320-000-008124 AMVK00124 1006-9320-000-008238 AMVK00130 1006-9320-000-008268 AMVK00131 1006-9320-000-008650 AMVK00145 1006-9320-000-008793 AMVK00157 1006-9320-000-008839 AMVK00241 1006-9320-000-008841 AMVK00160 1006-9320-000-008987 AMVK00197 1006-9320-000-008989 AMVK00194 1006-9320-000-009056 AMVK00214 1006-9320-000-009186 AMVK00226 1006-9320-000-009193 AMVK00245 1006-9320-000-009249 AMVK00138 1006-9320-000-009310 AMVK00257 1006-9320-000-009400 AMVK00254 1006-9320-000-009697 AMVK00271 1006-9320-000-009812 AMVK00270 1006-9320-000-009957 AMVK00278 1006-9320-000-010002 AMVK00324 1006-9320-000-010034 AMVK00315 1006-9320-000-010102 AMVK00322 1006-9320-000-010161 AMVK00332 1006-9320-000-010177 AMVK00314 1006-9320-000-010369 AMVK00392 1006-9320-000-010424 AMVK00390 1006-9320-000-010425 AMVK00388 1006-9320-000-010661 AMVK00401 1006-9320-000-010684 AMVK00400 1006-9320-000-010685 AMVK00405 1006-9320-000-010771 AMVK00409 1006-9320-000-010834 AMVK00410 1006-9320-000-010963 AMVK00417 1006-9320-000-011509 AMVK00562 1006-9320-000-012503 AMVK00537 1006-9320-000-013302 AMVK00560 1006-9320-000-013568 AMVK00568 1006-9320-000-013708 AMVK00569 1006-9320-000-013745 AMVK00583 1006-9320-000-013834 AMVK00596 1006-9320-000-014130 AMVK00601 1006-9320-000-014228 AMVK00697 1006-9320-000-014253 AMVK00657 1006-9320-000-014300 AMVK00691 1006-9320-000-014443 AMVK00722 1006-9320-000-014448 AMVK00711 1006-9320-000-014484 AMVK00720 1006-9320-000-014485 AMVK00721 1006-9320-000-014654 AMVK00730 1006-9320-000-014959 AMVK00709 1006-9320-000-015123 AMVL00107 1006-9320-000-015195 AMVL00111 1006-9320-000-015413 AMVL00202 1006-9320-000-015449 AMVL00125 1006-9320-000-016378 AMVL00204 1006-9320-000-016418 AMVJ00213 1006-9320-000-016482 AMVM00314 1006-9320-000-016493 AMVL00227 1006-9320-000-016508 AMVL00231 1006-9320-000-016526 AMVL00232 1006-9320-000-016622 AMVL00242 1006-9320-000-016717 AMVL00237 1006-9320-000-016857 AMVL00257 1006-9320-000-016976 AMVL00262 1006-9320-000-017086 AMVL00269 1006-9320-000-017427 AMVL00329 1006-9320-000-017498 AMVL00353 1006-9320-000-017555 AMVL00357 1006-9320-000-017639 AMVL00362 1006-9320-000-017640 AMVL00365 1006-9320-000-017643 AMVL00366 1006-9320-000-017852 AMVL00370 1006-9320-000-018713 AMVL00410 1006-9320-000-018778 AMVL00500 1006-9320-000-018938 AMVL00468 1006-9320-000-019424 AMVL00501 1006-9320-000-019818 AMVL00536 1006-9320-000-019882 AMVL00537 1006-9320-000-020078 AMVL00503 1006-9320-000-020140 AMVL00565 1006-9320-000-020339 AMVL00576 1006-9320-000-020434 AMVL00591 1006-9320-000-022424 AMVM00137 1006-9320-000-022497 AMVM00144 1006-9320-000-022596 AMVM00154 1006-9320-000-024820 AMVM00253 1006-9320-000-025679 AMVM00279 1006-9320-000-027285 AMVM00350 1006-9320-000-027347 AMVM00358 1006-9320-000-028131 AMVM00371 1006-9320-000-028794 AMVM00376 1006-9320-000-030200 AMVM00432 1006-9320-000-030201 AMVM00429 1006-9320-000-030259 AMVM00443 1006-9320-000-030509 AMVM00483 1006-9321-000 AMVF01711 1006-9321-000-000023 AMVL00115 1006-9321-000-000025 AMVJ00220 1006-9321-000-000028 AMVJ00228 1006-9321-000-000266 AMVJ00231 1006-9321-000-000533 AMVJ00260 1006-9321-000-000706 AMVH00767 1006-9321-000-000707 AMVH00814 1006-9321-000-001309 AMVJ00277 1006-9321-000-001974 AMVJ00354 1006-9321-000-002204 AMVJ00331 1006-9321-000-002205 AMVJ00333 1006-9321-000-002361 AMVJ00351 1006-9321-000-002671 AMVJ00302 1006-9321-000-003110 AMVJ00313 1006-9321-000-003229 AMVJ00310 1006-9321-000-003362 AMVJ00323 1006-9321-000-003385 AMVJ00356 1006-9321-000-003386 AMVJ00562 1006-9321-000-004230 AMVJ00395 1006-9321-000-004424 AMVJ00406 1006-9321-000-004524 AMVJ00391 1006-9321-000-004653 AMVL00270 1006-9321-000-004690 AMVJ00474 1006-9321-000-004778 AMVK00176 1006-9321-000-004831 AMVJ00390 1006-9321-000-004872 AMVJ00426 1006-9321-000-004874 AMVJ00430 1006-9321-000-004875 AMVJ00432 1006-9321-000-004961 AMVK00321 1006-9321-000-005258 AMVK00133 1006-9321-000-005398 AMVJ00437 1006-9321-000-005515 AMVJ00451 1006-9321-000-005642 AMVJ00490 1006-9321-000-005790 AMVJ00500 1006-9321-000-005839 AMVJ00476 1006-9321-000-005997 AMVN00485 1006-9321-000-005998 AMVJ00563 1006-9321-000-006318 AMVL00265 1006-9321-000-006645 AMVJ00532 1006-9321-000-006678 AMVJ00498 1006-9321-000-006777 AMVL00198 1006-9321-000-007145 AMVJ00548 1006-9321-000-007364 AMVJ00579 1006-9321-000-007378 AMVN00139 1006-9321-000-007474 AMVK00479 1006-9321-000-007480 AMVJ00590 1006-9321-000-007601 AMVM00499 1006-9321-000-007618 AMVK00102 1006-9321-000-007636 AMVM00373 1006-9321-000-007638 AMVJ00594 1006-9321-000-007639 AMVL00112 1006-9321-000-007641 AMVK00334 1006-9321-000-007642 AMVM00308 1006-9321-000-007762 AMVK00434 1006-9321-000-007785 AMVK00112 1006-9321-000-008072 AMVK00266 1006-9321-000-008305 AMVK00132 1006-9321-000-008508 AMVK00139 1006-9321-000-008526 AMVK00140 1006-9321-000-008529 AMVK00129 1006-9321-000-008643 AMVK00147 1006-9321-000-008747 AMVK00192 1006-9321-000-008781 AMVK00153 1006-9321-000-008798 AMVK00189 1006-9321-000-008799 AMVK00188 1006-9321-000-008872 AMVK00178 1006-9321-000-008881 AMVK00191 1006-9321-000-008954 AMVK00319 1006-9321-000-008963 AMVK00205 1006-9321-000-009244 AMVK00240 1006-9321-000-009266 AMVK00249 1006-9321-000-009293 AMVK00248 1006-9321-000-009297 AMVL00247 1006-9321-000-009347 AMVK00258 1006-9321-000-009449 AMVK00136 1006-9321-000-009805 AMVL00230 1006-9321-000-009930 AMVK00273 1006-9321-000-009966 AMVK00282 1006-9321-000-009982 AMVK00286 1006-9321-000-010025 AMVK00335 1006-9321-000-010029 AMVK00317 1006-9321-000-010167 AMVK00333 1006-9321-000-010209 AMVK00351 1006-9321-000-010213 AMVK00350 1006-9321-000-010215 AMVK00483 1006-9321-000-010236 AMVK00327 1006-9321-000-010584 AMVK00393 1006-9321-000-010911 AMVK00415 1006-9321-000-010970 AMVK00438 1006-9321-000-010974 AMVK00437 1006-9321-000-011001 AMVK00436 1006-9321-000-011148 AMVK00473 1006-9321-000-011348 AMVK00469 1006-9321-000-011434 AMVK00474 1006-9321-000-011524 AMVL00195 1006-9321-000-011702 AMVN00347 1006-9321-000-011809 AMVK00515 1006-9321-000-011836 AMVK00501 1006-9321-000-012769 AMVK00543 1006-9321-000-013303 AMVK00559 1006-9321-000-013304 AMVN00483 1006-9321-000-013425 AMVK00565 1006-9321-000-013437 AMVK00566 1006-9321-000-013784 AMVK00594 1006-9321-000-014028 AMVK00639 1006-9321-000-014090 AMVK00618 1006-9321-000-014246 AMVK00654 1006-9321-000-014262 AMVM00333 1006-9321-000-014264 AMVK00658 1006-9321-000-014273 AMVK00702 1006-9321-000-014274 AMVK00701 1006-9321-000-014347 AMVK00659 1006-9321-000-014521 AMVK00713 1006-9321-000-014553 AMVK00604 1006-9321-000-014996 AMVL00100 1006-9321-000-015096 AMVK00705 1006-9321-000-015166 AMVL00120 1006-9321-000-015180 AMVL00217 1006-9321-000-015405 AMVL00128 1006-9321-000-015552 AMVL00141 1006-9321-000-015594 AMVL00129 1006-9321-000-015790 AMVL00156 1006-9321-000-016412 AMVL00214 1006-9321-000-016415 AMVM00157 1006-9321-000-016563 AMVL00184MSN 1006-9321-000-016779 AMVL00235 1006-9321-000-017080 AMVL00267 1006-9321-000-017128 AMVL00276 1006-9321-000-017187 AMVL00278 1006-9321-000-017374 AMVL00307 1006-9321-000-017463 AMVL00426 1006-9321-000-017857 AMVL00360 1006-9321-000-018002 AMVL00338 1006-9321-000-018097 AMVL00375 1006-9321-000-018922 AMVL00442 1006-9321-000-018937 AMVL00484 1006-9321-000-019008 AMVL00478 1006-9321-000-019037 AMVL00399 1006-9321-000-019069 AMVL00485 1006-9321-000-019349 AMVL00507 1006-9321-000-019486 AMVL00521 1006-9321-000-019611 AMVL00526 1006-9321-000-019613 AMVL00525 1006-9321-000-019653 AMVL00528 1006-9321-000-019680 AMVL00524 1006-9321-000-019961 AMVL00542 1006-9321-000-020001 AMVL00535 1006-9321-000-020045 AMVL00551 1006-9321-000-020115 AMVM00140 1006-9321-000-020141 AMVL00568 1006-9321-000-020144 AMVL00567 1006-9321-000-020334 AMVL00575 1006-9321-000-020355 AMVN00458 1006-9321-000-020437 AMVL00579 1006-9321-000-021923 AMVM00117 1006-9321-000-022251 AMVM00129 1006-9321-000-022298 AMVM00132 1006-9321-000-022431 AMVQ00274 1006-9321-000-022432 AMVQ00113 1006-9321-000-022470 AMVM00164 1006-9321-000-022566 AMVM00351 1006-9321-000-022633 AMVM00155 1006-9321-000-022637 AMVM00158 1006-9321-000-022880 AMVM00179 1006-9321-000-023159 AMVM00182 1006-9321-000-023219 AMVM00185 1006-9321-000-023953 AMVM00202 1006-9321-000-024124 AMVP00350 1006-9321-000-024379 AMVM00224 1006-9321-000-024400 AMVM00225 1006-9321-000-024656 AMVM00230 1006-9321-000-024666 AMVM00231 1006-9321-000-024690 AMVM00232 1006-9321-000-024751 AMVM00248 1006-9321-000-024754 AMVM00247 1006-9321-000-024805 AMVM00250 1006-9321-000-025107 AMVM00262 1006-9321-000-025212 AMVM00275 1006-9321-000-025830 AMVM00281 1006-9321-000-025850 AMVM00282 1006-9321-000-026670 AMVM00311 1006-9321-000-026725 AMVM00313 1006-9321-000-027472 AMVM00284 1006-9321-000-027490 AMVM00367 1006-9321-000-027641 AMVM00369 1006-9321-000-027656 AMVM00366 1006-9321-000-029160 AMVM00379 1006-9321-000-029278 AMVM00384 1006-9321-000-029968 AMVM00416 1006-9321-000-030026 AMVM00392 1006-9321-000-030218 AMVM00440 1006-9321-000-030288 AMVQ00157 1006-9321-000-030321 AMVM00457 1006-9321-000-030377 AMVM00474 1006-9321-000-030386 AMVM00476 1006-9321-000-030387 AMVM00473 1006-9321-000-030530 AMVM00482 1006-9321-000-030570 AMVM00494 1006-9321-000-030610 AMVM00496 1006-9321-000-032054 AMVN00102 1006-9321-000-032086 AMVN00104 1006-9321-000-033581 AMVN00175 1006-9321-000-034801 AMVN00195 1006-9321-000-035978 AMVN00310 1006-9321-000-036850 AMVN00249 1006-9321-000-037070 AMVN00270 1006-9321-000-037146 AMVN00263 1006-9321-000-037245 AMVN00272 1006-9321-000-037328 AMVN00273 1006-9321-000-037346 AMVN00278 1006-9321-000-038554 AMVN00295 1006-9321-000-038703 AMVN00297 1006-9321-000-038954 AMVN00309 1006-9321-000-039161 AMVN00300 1006-9321-000-039834 AMVN00337 1006-9321-000-039892 AMVN00329 1006-9321-000-040613 AMVN00368 1006-9321-000-043264 AMVN00426 1006-9321-000-043401 AMVN00431 1006-9321-000-043612 AMVN00444 1006-9321-000-043867 AMVN00498 1006-9321-000-044061 AMVN00476 1006-9321-000-044171 AMVN00482 1006-9321-000-045644 AMVP00169 1006-9321-000-045828 AMVP00158 1006-9321-000-046240 AMVP00212 1006-9321-000-048100 AMVP00189 1006-9321-000-048199 AMVP00188 1006-9321-000-050007 AMVP00204 1006-9321-000-050429 AMVP00218 1006-9321-000-052669 AMVP00296 1006-9321-000-053555 AMVP00345 1006-9321-000-053598 AMVP00348 1006-9321-000-053774 AMVP00351 1006-9321-000-054415 AMVP00369 1006-9321-000-057815 AMVP00426 1006-9321-000-058531 AMVP00445 1006-9321-000-058777 AMVP00447 1006-9321-000-060684 AMVP00455 1006-9321-000-061177 AMVR00337 1006-9321-000-061248 AMVP00457 1006-9321-000-062679 AMVP00494 1006-9321-000-062680 AMVP00475 1006-9321-000-066198 AMVQ00110 1006-9321-000-066415 AMVQ00115 1006-9321-000-066671 AMVQ00136 1006-9321-000-068516 AMVQ00142 1006-9321-000-069786 AMVQ00163 1006-9321-000-075789 AMVQ00269 1006-9321-000-078292 AMVQ00298 1006-9321-000-079714 AMVQ00306 1006-9321-000-082032 AMVQ00324 1006-9321-000-082034 AMVQ00318 1006-9321-000-082035 AMVQ00316…
Recall started: July 19, 2019
Device type: Gas-Machine, Anesthesia
Root cause (FDA): Software in the Use Environment
What the company told customers: The firm sent an urgent medical device correction notice to their consignees by letter on 07/19/2019. The letter explained the issue and requested that the consignee ensure that the devices are connected to a sufficiently secure terminal server.
Recall number: Z-0117-2020

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0114-2020, Z-0115-2020, Z-0116-2020, Z-0117-2020. The agency record governs; check it and the company before acting.

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