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GE Healthcare, Aisys CS2 anesthesia..

FDA Device Recall #Z-1381-2016 — Class II — February 17, 2016

Recall Summary

Recall Number Z-1381-2016
Classification Class II — Moderate risk
Date Initiated February 17, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm GE Medical Systems, LLC
Location Waukesha, WI
Product Type Devices
Quantity 5496

Product Description

GE Healthcare, Aisys CS2 anesthesia..

Reason for Recall

GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia devices.

Distribution Pattern

US: AL, AZ, AR, CA, CO, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI. OUS: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, CANDA, CHILE, CHINA, COLOMBIA, CROATIA, CR¿CHE REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY,GREECE, HELSINKI, HONG KONG, HUNGARIA, ICELAND, INDIA, IRAQ, IRELAND, ITA LY, JAPAN, JORDAN, KAZAKHSTAN, KOREA, KUWAIT, MALAYSIA, MEXICO, MOLDOVA, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, PERU, POLAND, PORTUGAL QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM,URUGUAY, VIETNAM.

Lot / Code Information

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APWT02999 APWT03000 APWT03001 APWT03002 APWT03003 APWU02485 APWU02505 APWU02506 APWT00246 APWU01699 APWU01700 APWU01701 APWU01702 APWU01703 APWU01704 APWU01705 APWU01706 APWU01707 APWU01708 APWU01709 APWU01710 APWU02635 APWU02636 APWU02637 APWU02638 APWU02639 APWU02640 APWU02641 APWU02642 APWU02643 APWU02644 APWU02645 APWU02696 APWU02697 APWU02698 APWU02699 APWU02700 APWU02701 APWT00532 APWT02333 APWT02334 APWT02335 APWT02336 APWT02337 APWT02338 APWT02339 APWT02340 APWT02341 APWT00362 APWT00363 APWT03056 APWT03057 APWT00245 APWT00790 APWT02194 APWT00236 APWT00240 APWT00244 APWT02191 APWT02848 APWT02849 APWU01652 APWU01653 APWU01654 APWU01655 APWU01897 APWU02379 APWU02381 APWU01096 APWU01097 APWU01098 APWU01099 APWU01100 APWU01101 APWU01102 APWU01103 APWU01104 APWU01105 APWU01106 APWU01107 APWU01108 APWU01109 APWU01496 APWU01497 APWU01498 APWU01499 APWU01500 APWU01501 APWU01502 APWU01503 APWU01504 APWU01505 APWU01736 APWU01737 APWT00320 APWT00341 APWT00342 APWT00343 APWT00344 APWT00375 APWT00376 APWU01579 APWU01580 APWU01581 APWU01582 APWU00864 APWU00865 APWU00866 APWU00867 APWU00868 APWU00869 APWU00870 APWU00871 APWU01149 APWU01150 APWV00102 APWV00103 APWT00239 APWU00607 APWU00608 APWU00609 APWU00610 APWU02176 APWU01910 APWU00913 APWU01265 APWU01266 APWT02053 APWU01911 APWU01912 APWU01913 APWU01914 APWU00168 APWU00169 APWU00170 APWU00171 APWU02723 APWT00891 APWT00892 APWT02312 APWT02317 APWT02318 APWT02320 APWT02321 APWU01922 APWU01923 APWU01929 APWU01930 APWU01931 APWU01932 APWU01933 APWU01934 APWU01935 APWU01936 APWU01937 APWU01938 APWT02700 APWT02701 APWT02702 APWT02703 APWU02392 APWU02393 APWU02394 APWU02395 APWU02400 APWU02414 APWU02415 APWU02416 APWU02417 APWU02653 APWU02654 APWU02655 APWU02656 APWU02657 APWU02658 APWU02659 APWU02660 APWU02661 APWU02662 APWU02663 APWU02664 APWU02665 APWU02666 APWU02667 APWU02668 APWU02669 APWU02670 APWU02671 APWU02672 APWU01422 APWU00764 APWU00765 APWU00766 APWU00889 APWU02249 APWU02250 APWU02632 APWU02061 APWT00202 APWT00203 APWT00204 APWT03065 APWT03066 APWT03067 APWT03068 APWT03069 APWT03070 APWT03071 APWT03072 APWT03073 APWT03074 APWT03075 APWT03076 APWT03077 APWT03078 APWU01443 APWU01444 APWU01445 APWU01446 APWU01447 APWU01448 APWU01449 APWU01450 APWU01451 APWU01452 APWU01774 APWU01775 APWT02859 APWT02860 APWT02861 APWT02862 APWT02863 APWT02864 APWT02865 APWT02866 APWT02867 APWT02868 APWT03030 APWT03031 APWT03032 APWT03033 APWT03034 APWT03035 APWT03036 APWT03037 APWT03038 APWT03039 APWT03040 APWT03041 APWT03042 APWT03043 APWT03044 APWT03045 APWT03046 APWT03047 APWT03048 APWT03049 APWT03050 APWT03051 APWT03052 APWT03053 APWT03054 APWT03055 APWT00256 APWT00257 APWT02568 APWU01095 APWU00725 APWU00726 APWU00727 APWU01245 APWT02298 APWT02299 APWT02300 APWT02301 APWT02302 APWT02303 APWT02304 APWU00241 APWU00242 APWU00243 APWU00244 APWU00245 APWT02539 APWU01788 APWU01789 APWU01790 APWU01791 APWU01246 APWU01247 APWU01248 APWU02577 APWU02578 APWU02579 APWU02580 APWU02581 APWU02582 APWU02583 APWU00486 APWU00487 APWU00575 APWU01267 APWT03059 APWT03060 APWT03061 APWT03062 APWT03063 APWT03064 APWU02724 APWU02725 APWU02726 APWU02727 APWU02728 APWU02729 APWU02730 APWU02731 APWU02649 APWU02650 APWT03174 APWT03175 APWU01383 APWU01384 APWT03079 APWT03080 APWT03081 APWT03082 APWT03083 APWT03084 APWT03085 APWT03086 APWT03087 APWT03088 APWT03089 APWT03090 APWT03091 APWT03092 APWT03093 APWT03094 APWT03095 APWT03096 APWT03097 APWT03098 APWT03099 APWT03100 APWT03101 APWT03102 APWT03103 APWT03104 APWT03105 APWT03106 APWT00144 APWT00145 APWT00146 APWT00147 APWT00148 APWT00149 APWT00150 APWT00151 APWT00152 APWT00153 APWT00154 APWT00155 APWT02200 APWT00575 APWT00576 APWT00577 APWT00578 APWT00611 APWT00612 APWT00613 APWT00614 APWT00615 APWT00616 APWT00617 APWT00618 APWT00619 APWT00620 APWT00621 APWT00622 APWT00623 APWT00624 APWT00625 APWT00626 APWT00627 APWT00628 APWT00629 APWT00630 APWT00903 APWT00904 APWT00905 APWT00906 APWT00907 APWT00908 APWT00909 APWU01632 APWU01633 APWU01634 APWU02702 APWU02703 APWU02704 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APWT02906 APWT02907 APWT02908 APWT02909 APWT02910 APWT02911 APWT02912 APWT02913 APWT02914 APWT02915 APWT02916 APWT02917 APWT02918 APWT02919 APWT02920 APWT02921 APWT02922 APWT02923 APWT02924 APWU02647 APWU01114 APWU00937 APWU00938 APWU02053 APWU02054 APWU02055 APWU02056 APWU02057 APWU02058 APWU00540 APWU00541 APWU00542 APWU00543 APWU00621 APWU00622 APWU00623 APWU00624 APWU00625 APWU00626 APWU00627 APWU00628 APWU00629 APWU00630 APWU00631 APWU00632 APWU00633 APWU00634 APWU00635 APWU00636 APWU00637 APWU00638 APWU00639 APWU00640 APWU00641 APWU00642 APWU00643 APWU00644 APWU00645 APWU00646 APWU00647 APWU00648 APWU00649 APWU00650 APWU00651 APWU00652 APWU00653 APWU00654 APWU00655 APWU00656 APWU00657 APWU00658 APWU00659 APWU00660 APWU00661 APWU00662 APWU00663 APWU00664 APWU00665 APWU00666 APWU00667 APWU00668 APWU00669 APWU00670 APWU00671 APWU00672 APWU00673 APWU00674 APWU00675 APWU00676 APWU00677 APWU00678 APWT03013 APWT03014 APWT03015 APWT03016 APWT03017 APWT03018 APWT03019 APWT03020 APWT03021 APWT03022 APWT03023 APWT03024 APWT03025 APWT03026 APWT03027 APWT03028 APWT02246 APWT02247 APWV00138 APWV00139 APWU00573 APWU02068 APWU00250 APWU00252 APWU01345 APWT01007 APWT01008 APWS00175 APWS00176 APWS00177 APWS00178 APWS00179 APWS00180 APWS00181 APWS00182 APWS00183 APWS00184 APWS00185 APWS00186 APWS00187 APWS00188 APWU00274 APWU00275 APWU00276 APWU00277 APWU00278 APWU00279 APWU00280 APWU00281 APWU00282 APWU00283 APWU00284 APWU00285 APWU00286 APWU00287 APWU00288 APWU00289 APWU00290 APWU00291 APWU00292 APWU00106 APWU00107 APWU00108 APWU00109 APWU01360 APWU01361 APWU01362 APWU01363 APWU01364 APWU01365 APWU01366 APWU01367 APWU01368 APWU01369 APWU01370 APWU01088 APWU01089 APWU01090 APWU01346 APWU01347 APWU00114 APWU00485 APWU01426 APWU02589 APWU02590 APWU02591 APWU02592 APWU02593 APWU02594 APWU02595 APWU02596 APWU02597 APWU02598 APWU02297 APWU02298 APWU02299 APWU02300 APWU02301 APWU02302 APWU02303 APWU02304 APWT02419 APWU01794 APWU01795 APWU01796 APWU01826 APWU01348 APWU01349 APWU01350 APWU01351 APWU01352 APWU01353 APWU01354 APWU01355 APWU01356 APWU01357 APWU01358 APWU01898 APWU01899 APWU01900 APWU01901 APWU01902 APWU01903 APWU01296 APWU01297 APWU01298 APWU01299 APWU01300 APWU01301 APWU01302 APWU01303 APWU01304 APWU01305 APWU01306 APWU01307 APWU01308 APWU01309 APWU01310 APWU01311 APWU01312 APWU01313 APWU01314 APWU01315 APWU01316 APWU01317 APWU01318 APWU01319 APWU01320 APWU01321 APWU01322 APWU01323 APWU01324 APWU01325 APWU01326 APWU01327 APWU01328 APWU01329 APWU01330 APWU01331 APWU01332 APWU01333 APWU01334 APWU01335 APWU01336 APWU01337 APWU01338 APWT02540 APWT02541 APWT02542 APWT02543 APWT00588 APWT02664 APWT02666 APWT02667 APWT02669 APWT02670 APWT02671 APWT02672 APWT00247 APWT00793 APWT02665 APWT02668 APWU02175 APWU00208 APWU00529 APWU00530 APWU00531 APWU00532 APWU00533 APWT02892 APWU01083 APWT00969 APWT00970 APWT00971 APWT00972 APWT00973 APWT00974 APWT00975 APWT00976 APWT02535 APWT00794 APWT00985 APWT00986 APWT00987 APWT00988 APWT00989 APWT00990 APWV00114 APWV00115 APWV00116 APWV00117 APWV00118 APWV00119 APWV00120 APWV00121 APWV00122 APWT00961 APWT00962 APWT00963 APWT00964 APWT00965 APWT00966 APWT00967 APWU01155 APWU01156 APWU01196 APWU01197 APWU01198 APWU01199 APWU01200 APWU01201 APWU01202 APWU01203 APWU01204 APWU01205 APWT01037 APWU00756 APWU00757 APWU00758 APWU00759 APWU00760 APWU00761 APWU00762 APWU00763 APWU01161 APWU01162 APWU01163 APWU01249 APWU02115 APWU02116 APWU02117 APWU02118 APWU02119 APWU02120 APWU02121 APWU02122 APWU02123 APWU02124 APWU02125 APWU02126 APWU02127 APWU02128 APWU02129 APWU02130 APWU02131 APWU02132 APWU02133 APWU02134 APWU02135 APWU02136 APWU02137 APWU02138 APWU02139 APWU02140 APWU02141 APWU02142 APWU02143 APWU01681 APWU01682 APWU01683 APWT00604 APWT00605 APWT00606 APWT00607 APWU01924 APWU01925 APWU01926 APWU01927 APWU02104 APWU01168 APWU01169 APWU01170 APWU01171 APWU01172 APWU01173 APWU01174 APWU01175 APWU01176 APWU01177 APWU01178 APWU01179 APWU01180 APWU01181 APWU01182 APWU01183 APWU01184 APWU01185 APWU01186 APWU01187 APWU01188 APWU01189 APWU01190 APWU00534 APWU00535 APWU00536 APWU00537 APWU01939 APWU01940 APWU01941 APWU01942 APWU01943 APWU01781 APWT02884 APWT02885 APWT02886 APWT02887 APWT02888 APWT02889 APWT02890 APWT02891 APWU01782 APWU01783 APWU02105 APWU02106 APWU02107 APWU01571 APWU01572 APWU01573 APWU01574 APWU01575 APWU01584 APWU01585 APWU01586 APWU01587 APWU01885 APWU01886 APWU02177 APWU02178 APWU02179 APWU02180 APWT02011 APWU00121 APWU01676 APWU02389 APWU02390 APWU02391 APWU01828 APWU01829 APWT00250 APWU00509 APWU00510 APWU00511 APWT02517 APWT02518 APWT02519 APWT02520 APWT02521 APWU00568 APWU00569 APWU00570 APWU00571 APWU00572 APWT00787 APWT00788 APWT02504 APWT02505 APWU00577 APWU00578 APWT02437 APWU00512 APWT02253 APWT02192 APWT02778 APWT02779 APWT02780 APWT02781 APWT02782 APWT02783 APWT02784 APWT02785 APWT02786 APWT02787 APWT02788 APWT02789 APWT03128 APWT03129 APWT00243 APWU01157 APWU01158 APWU01159 APWU01160 APWU01418 APWT00253 APWT00254 APWT02722 APWT02723 APWT02724 APWT02410 APWT02411 APWT02412 APWT02413 APWT02414 APWT02415 APWU01797 APWU01798 APWT03130 APWT03131 APWT03132 APWT03133 APWT03134 APWT03135 APWU02709 APWU02710 APWU02711 APWU02712 APWU02713 APWU02714 APWU02715 APWU02716 APWU01638 APWU01639 APWU01640 APWT02406 APWT02704 APWU01520 APWU01521 APWU01522 APWU01523 APWU00574 APWU01191 APWU01192 APWU01529 APWU01999 APWU02000 APWU02001 APWU02002 APWU02003 APWU02004 APWU02005 APWU02006 APWU02007 APWU02008 APWU02009 APWU02010 APWU02011 APWU02012 APWU02013 APWU02014 APWU02015 APWU02584 APWT00817 APWT00818 APWT00819 APWT00820 APWT02189 APWU01624 APWU01625 APWU01626 APWU01627 APWU01628 APWU01629 APWU01630 APWU01631 APWU02064 APWU02065 APWU02633 APWU02634 APWT00821 APWT00822 APWT00823 APWT00824 APWT00825 APWT00826 APWT00827 APWT00828 APWT00829 APWT00830 APWT00831 APWT00832 APWT00833 APWT00834 APWT00835 APWT00836 APWU01421 APWU00149 APWU00150 APWU00151 APWU00152 APWU00153 APWU00154 APWU00155 APWU00156 APWU00157 APWT00472 APWT00473 APWT00597 APWT00598 APWT02708 APWT02709 APWT02710 APWT02711 APWT02712 APWT02995 APWU00990 APWU00991 APWU00992 APWU00993 APWU00994 APWU00995 APWU00996 APWU00997 APWU00998 APWU00999 APWU02305 APWU02306 APWT01038 APWU00139 APWU00714 APWU00715 APWU00716 APWU00717 APWU00718 APWU01193 APWU01194 APWU01195 APWT03136 APWT03137 APWT03138 APWT03139 APWT03140 APWT03141 APWT03142 APWT03143 APWT03144 APWT03145 APWT03146 APWT03147 APWT03148 APWT03149 APWT03150 APWU00294 APWU01413 APWU01414 APWU01415 APWT02462 APWT02463 APWT02464 APWT02465 APWT02466 APWT02467 APWT02468 APWT02259 APWT02260 APWT02261 APWT02262 APWT02263 APWT02264 APWT02265 APWT02266 APWT02267 APWT02268 APWT02269 APWT02270 APWT02271 APWT02272 APWT02273 APWT02274 APWT02275 APWT02285 APWT02286 APWT02287 APWT02288 APWT02289 APWT02290 APWT02306 APWT02307 APWT02309 APWT02310 APWT02311 APWT02343 APWT02344 APWT02345 APWT02347 APWT02348 APWT02349 APWT02350 APWT02351 APWT02352 APWT02353 APWT02354 APWT02355 APWT02356 APWT02357 APWT02358 APWT02359 APWT02360 APWT02361 APWT02362 APWT02363 APWT02364 APWT02365 APWT02366 APWT02367 APWT02368 APWT02369 APWT02370 APWT02371 APWT02372 APWT02373 APWT02374 APWT02375 APWT02376 APWT02377 APWT02378 APWT02379 APWT02380 APWT02381 APWT02382 APWT02420 APWT02421 APWT02422 APWT02423 APWT02424 APWT02425 APWT02426 APWT02427 APWT02428 APWT02429 APWT02430 APWT02438 APWT02439 APWT02440 APWT02441 APWT02442 APWT02443 APWT02444 APWT02445 APWT02447 APWT02448 APWT02449 APWT02450 APWT02451 APWT02452 APWT02453 APWT02454 APWT02455 APWT02456 APWT02457 APWT02458 APWT02459 APWT02460 APWT02461 APWT02576 APWT02577 APWT02578 APWT02579 APWT02580 APWT02581 APWT02582 APWT02583 APWT02584 APWT02585 APWT02586 APWT02587 APWT02588 APWT02589 APWT02590 APWT02591 APWT02592 APWT02593 APWT02594 APWT02674 APWT02675 APWT02676 APWT02677 APWT02727 APWT02947 APWT02948 APWT02949 APWT02950 APWT02951 APWT02952 APWT02953 APWT02954 APWT02955 APWT02956 APWU00508 APWT02383 APWU02396 APWU02397 APWU02398 APWU02399 APWU02457 APWU02458 APWU02459 APWU02425 APWU02426 APWU02427 APWT00601 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APWT02203 APWT02204 APWT02205 APWT02206 APWT02207 APWT02208 APWU00912 APWU02201 APWU01377 APWU01786 APWT02715 APWT02716 APWU00513 APWU00514 APWU00558 APWT02017 APWT02018 APWU00143 APWU00144 APWU01635 APWU01636 APWT00531 APWU00246 5408943-1 5408943-2 5408943-3 5408943-4 5408943-5 APWS00106 APWS00107 APWS00108 APWS00109 APWS00110 APWS00111 APWS00112 APWS00113 APWS00114 APWS00115 APWU01838 APWU01839 APWU01840 APWU01841 APWU01844 APWU02109 APWU02374 APWU02375 APWU02585 APWU02586 APWU02587 APWU02588 APWV00171 APWV00172 APWV00190 APWV00191 APWV00192 APWV00193 APWV00194 APWV00195 APWV00196 APWV00197 APWV00198 APWV00199 APWV00200 APWV00201 APWV00202 APWV00203 APWV00204 APWV00205 APWV00207 APWV00208 APWV00209 APWV00210 APWV00218 APWV00219 APWV00220 APWV00221 APWV00222 APWV00223 APWV00224 APWV00234 APWV00235 APWV00236 APWV00237 APWV00238 APWV00239 APWV00240 APWV00241 APWV00242 APWV00243 APWV00244 APWV00245 APWV00246 APWV00247 APWV00248 APWV00249 APWV00250 APWV00252 APWV00253 APWV00255 APWV00256 APWV00259 APWV00260 APWV00261 APWV00264 APWV00265 APWV00284 APWV00285 APWV00286 APWV00295 APWV00296 APWV00297 APWV00298 APWV00299 APWV00300 APWV00301 APWV00302 APWV00303 APWV00304 APWV00305 APWV00306 APWV00307 APWV00308 APWV00314 APWV00315 APWV00316 APWV00317 APWV00318 APWV00319 APWV00322 APWV00323 APWV00325 APWV00327 APWV00328 APWV00329 APWV00331 APWV00332 APWV00333 APWV00334 APWV00335 APWV00336 APWV00337 APWV00338 APWV00339 APWV00340 APWV00342 APWV00343 APWV00344 APWV00353 APWV00355 APWU01000 APWU01001 APWU01002 APWU01003 APWU01004 APWU01005 APWU01006 APWU01007 APWU01008 APWU01009 APWU01010 APWU01011 APWU01012 APWU01013 APWU01014 APWU01015 APWU01016 APWU01017 APWU01018 APWU01019 APWU01020 APWU01021 APWS00101 APWS00102 APWS00104 APWS00105 APWT02850 APWT02196 APWT02197 5405278 5402641-1 5402641-2 5402641-3 5402641-4 5404412-1 5404412-2 5404412-3 5404412-4 5404412-5 APWT02190 APWU00325 APWU00402 APWU00403 APWU01371 APWU01372 APWU01373 APWU01374 APWU01375 APWU01376 APWU01918 APWU01919 APWU01920 APWU01921 APWU01642 APWU01643 APWU01644 APWU01645 APWU01646 APWU01647 APWU01648 APWU01649 APWU02200 APWT00237 APWT00241 APWT00792 APWT02122 APWT02123 APWT02124 APWT02125 APWT02126 APWT02127 APWT02193 APWT02195 APWT00585 APWT00586 APWU00722 APWT02102 APWU00130 APWU00131 APWU00132 APWU00133 APWU00134 APWU00135 APWU01435 APWU01436 APWU01437 APWU01438 APWU01439 APWU01440 APWU01441 APWU01442 APWU00551 APWU00552 APWU00553 APWU00554 APWU00555 APWU00556 APWU00557 APWU00825 APWU01135 APWU01136 APWU01137 APWU01138 APWU01139 APWU01140 APWU01141 APWU01142 APWU02323 APWU02324 APWS00236 APWS00415 APWS00416 APWS00417 APWS00418 APWS00419 APWS00420 APWS00421 APWS00452 APWT02297 APWU02030 APWU02031 APWU02072 APWU02073 APWU02074 APWU02075 APWU02076 APWU02077 APWU02078 APWU02079 APWU02080 APWU02092 APWU02093 APWU02094 APWU02095 APWU02096 APWU02097 APWU02113 APWU02159 APWU02160 APWU02161 APWU02162 APWU02246 APWU02288 APWU02290 APWU02332 APWU02410 APWU02411 APWU02412 APWU02413 APWU02501 APWU02651 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APWT00696 APWT00700 APWT00701 APWT00708 APWT00709 APWT00714 APWT00716 APWT00718 APWT00779 APWT00780 APWT00781 APWT00782 APWT00783 APWT00784 APWT02107 APWT02108 APWT02109 APWT02110 APWT02111 APWT02112 APWT02113 APWT02114 APWT02199 APWT02820 APWU00115 APWU00116 APWU00117 APWS00373 APWS00374 APWS00375 APWS00376 APWS00377 APWU00884 APWU00122 APWU00123 APWU00124 APWU00125 APWT02404 APWT02531 APWT02532 APWT02533 APWT02534 APWT00785 APWT00786 APWU01419 APWS00117 APWS00453 APWS00461 APWU00925 APWU00926 APWS00458 APWS00460 APWT00885 APWT02798 APWT02405 APWU00180 APWU00172 APWU00173 APWU00174 APWT00844 APWS00232 APWU00488 APWU00489 APWU00490 APWU00491 APWU00492 APWU00493 APWU00494 APWU00495 APWU00496 APWU00313 APWT02662 APWT02403 APWT02714 APWT02826 APWT02818 APWT02819 APWT00896 APWT00897 APWT00421 APWT00422 APWT00423 APWT00424 APWT00425 APWT00426 APWT00427 APWT00428 APWT00429 APWT00811 APWU00989 APWT00771 APWT02673 APWS00455 APWU00799 APWU00800 APWT00124 APWT00125 APWT00126 APWT00127 APWT00128 APWT00129 APWT02399 APWT02400 APWT02401 APWT02402 APWS00454 APWS00457 APWS00459 APWS00456 APWS00485 APWT00369 APWT00812 APWT00813 APWT00814 APWT02001 APWT02002 APWT02003 APWT02004 APWT02005 APWT02006 APWT02007 APWT02008 APWT01017 APWU00914 APWS00407 APWS00408 APWS00409 APWS00410 APWS00411 APWS00412 APWS00413 APWT00579 APWT02831 APWT02832 APWT02833 APWT02834 APWU00898 APWT00770 APWT00769 APWU00826 APWT02063 APWT02064 APWT02065 APWS00167 APWS00168 APWS00169 APWS00170 APWS00171 APWS00172 APWS00173 APWS00174 APWT00699 APWT00717 APWS00233 APWT03117 APWU00822 APWU00823 APWU00824 APWU00872 APWU00873 APWU00874 APWT02680 APWT02836 APWT02837 APWT02838 APWT01013 APWT01014 APWU01807 APWU01808 APWT02828 APWS00378 APWU00915 APWS00379 APWS00380 APWU00836 APWT00110 APWT00111 APWT00112 APWT00113 APWT00114 APWT00115 APWT00116 APWT00117 APWT00118 APWU01111 APWT00364 APWT00365 APWT00366 APWT00367 APWT00368 APWT02827 APWU00370 APWU00371 APWS00433 APWS00434 APWS00435 APWS00436 APWS00437 APWU00307 APWS00430 APWS00431 APWS00432 APWU01110 APWU01112 APWT00435 APWT00749 APWT02234 APWT02235 APWT02236 APWS00531 APWT00134 APWS00422 APWU01887 APWU01888 APWU01889 APWS00155 APWS00156 APWS00157 APWS00216 APWS00217 APWS00251 APWS00252 APWS00256 APWS00257 APWS00258 APWS00259 APWS00260 APWS00446 APWS00552 APWT00183 APWT00199 APWT00200 APWT00201 APWT00251 APWT00252 APWT00255 APWT00742 APWT00743 APWT00927 APWT00928 APWT02033 APWT02034 APWT02035 APWT02036 APWT02037 APWT02038 APWT02039 APWT02040 APWT02041 APWT02042 APWT02506 APWT02507 APWT02508 APWT02509 APWT02510 APWT02511 APWT02513 APWT02530 APWT02879 APWT02880 APWT02935 APWU00317 APWU00318 APWU00783 APWU00784 APWU00785 APWU01117 APWU01118 APWU01119 APWU01120 APWU01121 APWU01122 APWT00845 APWS00138 APWS00140 APWS00218 APWS00219 APWS00220 APWS00221 APWS00222 APWS00223 APWS00266 APWS00267 APWS00316 APWS00317 APWS00318 APWS00319 APWS00320 APWS00321 APWS00322 APWS00543 APWT00213 APWT00214 APWT00215 APWT00216 APWT00217 APWT00218 APWT00219 APWT00220 APWT00221 APWT00222 APWT00223 APWT00503 APWT00504 APWT00505 APWT00506 APWT00507 APWT00508 APWT00509 APWT00510 APWT00511 APWT00512 APWT00530 APWT00595 APWT00837 APWT00838 APWT00839 APWT00840 APWT00841 APWT00842 APWT00843 APWT00900 APWT00901 APWT02055 APWT02141 APWT02142 APWT02143 APWT02144 APWT02145 APWT02146 APWT02147 APWT02148 APWT02681 APWU00111 APWU00112 APWU00412 APWU00464 APWU00465 APWU00466 APWU00467 APWU00468 APWU00469 APWU00470 APWU00471 APWU00472 APWU00473 APWU00886 APWU00887 APWU00888 APWU01904 APWT00258 APWT00259 APWT00260 APWT00261 APWT00262 APWT02103 APWU00319 APWU00320 APWU00321 APWU00322 APWU00323 APWU01290 APWU01291 APWU02153 APWU01981 APWU02233 APWU02234 APWU02235 APWU02247 APWU01787 APWU00545 APWU01982 APWU01983 APWU01984 APWU01985 APWU01986 APWU01987 APWU00353 APWU00827 APWT02009 APWT02957 APWT02958 APWT02959 APWT02960 APWT02961 APWT02979 APWT00460 APWT00547 APWT00548 APWT00549 APWT00550 APWT00551 APWT00552 APWT00855 APWT02313 APWT02314 APWT02315 APWT02316 APWT02319 APWT02322 APWT02821 APWT02822 APWT02823 APWT02824 APWT02825 APWU00840 APWU00841 APWU00842 APWU00843 APWU00844 APWU00845 APWU00846 APWU00847 APWT00438 APWT00884 APWU00247 APWT00940 APWU00936 APWS00381 APWS00382 APWS00383 APWT02284 APWT00539 APWT00540 APWT00541 APWT00346 APWT00347 APWT00348 APWT00349 APWT00350 APWT00351 APWT00352 APWU00211 APWU00212 APWU00213 APWU00214 APWU01761 APWU01762 APWU01763 APWU01764 APWU01765 APWU01766 APWU01767 APWU01768 APWU01769 APWU01770 APWU01771 APWU01772 APWU01773 APWT02946 APWT00722 APWT00723 APWT00724 APWT00725 APWT00726 APWT00727 APWT00728 APWT00729 APWT00730 APWT00731 APWT00732 APWT00733 APWT00439 APWT00440 APWT02162 APWU00891 APWU00892 APWT00377 APWU00343 APWU00933 APWU00934 APWU00935 APWS00505 APWS00506 APWS00507 APWS00508 APWS00509 APWS00544 APWS00545 APWS00546 APWS00547 APWS00548 APWS00549 APWS00550 APWT02387 APWT02388 APWT00475 APWT00476 APWT02342 APWU01220 APWU01221 APWU01222 APWU01223 APWU01224 APWU01225 APWU01226 APWU01227 APWU01228 APWU01229 APWU01230 APWU01231 APWU01232 APWU01233 APWU01234 APWU01235 APWU01236 APWU01237 APWU01238 APWU01239 APWU01255 APWU01256 APWU01257 APWU01258 APWU01259 APWU01260 APWU01261 APWU01262 APWU01263 APWU01264 APWU01268 APWU01269 APWU01270 APWU01271 APWU01272 APWU01273 APWU01274 APWU01275 APWU01276 APWU01277 APWU01278 APWU01279 APWU01280 APWU01281 APWU01282 APWU01283 APWU01284 APWU01285 APWU01286 APWU01287 APWU01288 APWU01289 APWT02416 APWU01206 APWU01207 APWU01208 APWU01209 APWU01210 APWU01211 APWU01212 APWU01213 APWU01214 APWU01215 APWU01216 APWU01217 APWU01218 APWU01219 APWU00191 APWU00192 APWU00193 APWU00194 APWU00195 APWU00196 APWU00197 APWU00198 APWT00141 APWT00142 APWT00143 APWT00542 APWT00543 APWT00544 APWT00545 APWT00546 APWU01458 APWU01459 APWU01460 APWU00931 APWU00932 APWS00482 APWU00391 APWU00450 APWU00181 APWU00615 APWU00616 APWU00617 APWU00618 APWU00233 APWU00234 APWU00235 APWU00236 APWU00237 APWU00238 APWU01818 APWU01819 APWU01820 APWU01821 APWU01822 APWU01823 APWU01824 APWT00991 APWT00992 APWT00993 APWT00994 APWT00995 APWU01928 APWS00484 APWU00930 APWU01851 APWU01852 APWU01853 APWU01854 APWU01855 APWU01856 APWU01857 APWU01858 APWU01859 APWU01860 APWU01861 APWU01862 APWU01863 APWU01864 APWU01865 APWU01866 APWU01867 APWU01868 APWU01869 APWU01870 APWU01871 APWU01872 APWU01873 APWU01874 APWU01875 APWU00939 APWU00940 APWU00941 APWU01029 APWU01030 APWU01031 APWU01032 APWU01033 APWU01034 APWU01035 APWU01036 APWU01037 APWU01038 APWU01039 APWU01040 APWU01041 APWU01042 APWU01043 APWU01044 APWU01045 APWU01046 APWU01047 APWU01048 APWU01049 APWU01050 APWU01051 APWU01387 APWU01388 APWU01389 APWU01390 APWU01391 APWU01392 APWU01393 APWU01394 APWU01395 APWU01396 APWU01397 APWU00679 APWU00680 APWU00681 APWU00682 APWU00683 APWU00684 APWU00685 APWU00686 APWU00687 APWU00688 APWU00689 APWU00690 APWU00691 APWU00692 APWU00693 APWU00694 APWU00695 APWU00696 APWU00697 APWU00698 APWU00699 APWU00700 APWU00701 APWU00702 APWU00703 APWU00704 APWU00705 APWU01661 APWU01662 APWU01663 APWU01664 APWT00913 APWT00914 APWT00156 APWT00157 APWU00119 APWU00120 APWT00734 APWT00735 APWT00736 APWT00737 APWT00738 APWT00739 APWT00740 APWT00741 APWT00140 APWT02984 APWT00931 APWT00674 APWT00675 APWT00676 APWT00677 APWT00678 APWT00679 APWT00680 APWT00681 APWT00682 APWT00683 APWT00684 APWU00199 APWU00200 APWU00201 APWU00202 APWU00203 APWU00204 APWU00205 APWU00206 APWU00207 APWT02962 APWT02963 APWT02964 APWT02965 APWT02966 APWT02967 APWT02968 APWT02969 APWT02970 APWT02971 APWT02972 APWT02973 APWT02974 APWT02975 APWT02976 APWU00421 APWU00422 APWU00423 APWU00424 APWU00425 APWU00426 APWU00427 APWU00428 APWU00429 APWU00430 APWU00431 APWU00432 APWU00433 A

Other Recalls from GE Medical Systems, LLC

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Z-1590-2026 Class II Imactis CT-Navigation System, stereotaxic acces... Feb 3, 2026
Z-1569-2026 Class II Centricity Universal Viewer Software Versions 7... Jan 30, 2026
Z-1570-2026 Class II Centricity Universal Viewer Software Versions 6... Jan 30, 2026
Z-1571-2026 Class II Centricity Universal Viewer Software Versions 5... Jan 30, 2026
Z-0875-2026 Class II Senographe Pristina, Pristina Serena, and Prist... Oct 24, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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