GE Healthcare Engstrom Carestation…

Date

March 25, 2015

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

Product

GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators.

Reason

Potential failure of the caster mounting hardware, which may result in the ventilator falling/tipping (overbalancing).

Distribution pattern

Worldwide Distribution. US nationwide, ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, CANADA, CAMEROON, CANDA, CHILE, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, CHANA, GREECE, GUATEMALA, HONDURAS, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LEBANON, LIBYAN ARAB JAMAHIRIYA, MACEDONIA, MALAYSIA, MALTA , MEXICO, MOROCCO, NETHERLANDS, OMAN, PANAMA, PAPUA NEW GUINEA, PERU, POLAND, PORTUGAL, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, SYRIAN ARAB REPUBLIC, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM, VENEZUELA, and URUGUAY.

Quantity

3,213 (437 US, 2,776 OUS)

Codes and lots

Mfg Lot or Serial # CBCP02195 CBCP02196 CBCP02201 CBCP01764 CBCP01766 CBCP02109 CBCP01273 CBCP01409 CBCP01506 CBCP01528 CBCP01533 CBCP01538 CBCP01554 CBCP01629 CBCP01630 CBCP01631 CBCP01632 CBCP01635 CBCP01636 CBCP01638 CBCP01639 CBCP01641 CBCP01642 CBCP01379 CBCP01380 CBCP01400 CBCP01408 CBCP01411 CBCP01417 CBCP01419 CBCP01420 CBCP01423 CBCP01425 CBCP01489 CBCP01490 CBCP01491 CBCP01494 CBCP01496 CBCP01501 CBCP01530 CBCP01540 CBCP01541 CBCP01562 CBCP01615 CBCP01619 CBCP01721 CBCP01724 CBCP01725 CBCP01726 CBCP01727 CBCP01733 CBCP01748 CBCP01116 CBCP01383 CBCP01402 CBCP01403 CBCP01429 CBCP01497 CBCP01560 CBCP01579 CBCP01580 CBCP01623 CBCP01660 CBCP01661 CBCP01704 CBCP01708 CBCP01723 CBCP01728 CBCP01730 CBCP01731 CBCP01734 CBCP01736 CBCP01737 CBCP01740 CBCP01744 CBCP01745 CBCP01746 CBCP01749 CBCP01750 CBCP01751 CBCP01755 CBCP01084 CBCP01092 CBCP01122 CBCP01248 CBCP01250 CBCP01254 CBCP01255 CBCP01258 CBCP01267 CBCP01271 CBCP01280 CBCP01236 CBCP01241 CBCP00124 CBCP00126 CBCP00130 CBCP00131 CBCP00133 CBCP00134 CBCP00139 CBCP00140 CBCP00145 CBCP00147 CBCP00148 CBCP00156 CBCP00165 CBCP00167 CBCP00170 CBCQ00598 CBCQ00643 CBCQ00650 CBCQ00662 CBCQ00666 CBCQ00667 CBCQ00668 CBCQ00690 CBCQ00998 CBCQ01003 CBCQ01008 CBCQ01009 CBCQ01010 CBCQ01011 CBCQ01013 CBCQ01014 CBCQ00941 CBCQ00942 CBCQ00946 CBCQ00957 CBCQ01018 CBCQ01023 CBCQ01029 CBCQ01038 CBCQ01041 CBCQ01045 CBCQ01048 CBCP01861 CBCP01905 CBCP01910 CBCN01376 CBCN01377 CBCN01485 CBCN01497 CBCN01504 CBCN01505 CBCN01507 CBCN01508 CBCN01509 CBCN01513 CBCN01527 CBCP00784 CBCP00795 CBCP00816 CBCP00532 CBCP00710 CBCP00747 CBCP00753 CBCP00754 CBCP01208 CBCN01858 CBCN01860 CBCN01893 CBCN01894 CBCP00831 CBCP00870 CBCP00875 CBCP00885 CBCP01627 CBCP01828 CBCP01851 CBCP01916 CBCQ00596 CBCQ00630 CBCQ00632 CBCQ00638 CBCQ00640 CBCQ00641 CBCQ00645 CBCQ00655 CBCQ00657 CBCQ00658 CBCQ00669 CBCQ00672 CBCQ00686 CBCQ00706 CBCQ00722 CBCQ00727 CBCQ00734 CBCQ00736 CBCN01901 CBCN01927 CBCN01898 CBCN01903 CBCN01907 CBCN01909 CBCP02202 CBCP02192 CBCN01445 CBCN01514 CBCN01515 CBCN01879 CBCN01880 CBCN01896 CBCN01899 CBCN01911 CBCN01925 CBCN01928 CBCN01929 CBCN01930 CBCN01957 CBCQ00691 CBCN01842 CBCN01853 CBCN01904 CBCN01906 CBCN01908 CBCN01926 CBCN01217 CBCN01219 CBCN01231 CBCN01233 CBCN01237 CBCN01238 CBCN01239 CBCN01241 CBCN01242 CBCN01245 CBCP01272 CBCP01397 CBCP01401 CBCP01404 CBCP01421 CBCP01500 CBCP01507 CBCP01524 CBCP01569 CBCP01570 CBCP01574 CBCP01575 CBCP01576 CBCP01577 CBCP01578 CBCP01581 CBCP01633 CBCP01634 CBCP01637 CBCP01640 CBCP01648 CBCP01649 CBCQ00164 CBCQ00293 CBCQ00299 CBCQ00304 CBCQ00333 CBCQ00334 CBCQ00378 CBCQ00389 CBCQ00392 CBCQ00396 CBCQ00415 CBCQ00419 CBCQ00423 CBCQ00230 CBCQ00249 CBCQ00312 CBCQ00330 CBCQ00375 CBCQ00376 CBCQ00390 CBCQ00422 CBCQ01348 CBCQ01349 CBCQ01351 CBCQ01352 CBCQ01344 CBCQ01364 CBCQ01371 CBCQ01372 CBCQ01379 CBCQ01386 CBCQ01392 CBCQ01396 CBCP00954 CBCP01012 CBCP01050 CBCP01051 CBCP01053 CBCP01054 CBCP01055 CBCP01056 CBCP01057 CBCP01058 CBCP01059 CBCP01060 CBCP00582 CBCP01233 CBCP01467 CBCP00580 CBCP01087 CBCP01094 CBCP01098 CBCQ01251 CBCP00500 CBCP00515 CBCP00519 CBCP00528 CBCP00590 CBCP00852 CBCP00858 CBCP00869 CBCP00872 CBCP00877 CBCP00586 CBCP00802 CBCP00807 CBCP00675 CBCP01080 CBCP01088 CBCP01090 CBCP01093 CBCP01095 CBCP01097 CBCP01099 CBCP01120 CBCQ00944 CBCQ00740 CBCQ00741 CBCQ00743 CBCQ00745 CBCQ00940 CBCP01023 CBCP01024 CBCP01026 CBCP01027 CBCP01028 CBCP01029 CBCP01031 CBCP01033 CBCP01034 CBCP01035 CBCP01037 CBCP01215 CBCP01219 CBCP01223 CBCN01919 CBCN01934 CBCP01476 CBCP01478 CBCQ00887 CBCQ00888 CBCQ00889 CBCQ00890 CBCQ00891 CBCN01225 CBCN01243 CBCN01296 CBCN01298 CBCN01342 CBCN01347 CBCN01348 CBCN01346 CBCN01351 CBCN01354 CBCN01366 CBCP00125 CBCN01620 CBCP00119 CBCP00122 CBCP00123 CBCP00531 CBCP01372 CBCP01396 CBCP01801 CBCP01802 CBCP01794 CBCP01812 CBCP01962 CBCP01964 CBCP01956 CBCP02102 CBCP02198 CBCQ00287 CBCP01000 CBCP01001 CBCP01002 CBCP01003 CBCP00975 CBCP00978 CBCP01044 CBCP01048 CBCP01061 CBCP01062 CBCP01081 CBCP01083 CBCP01221 CBCP01453 CBCP01454 CBCP01469 CBCP01470 CBCP01471 CBCP01473 CBCP01485 CBCP01488 CBCP00865 CBCP01412 CBCP01424 CBCP01451 CBCN01353 CBCN01915 CBCN01918 CBCN01921 CBCN01990 CBCN01991 CBCN01992 CBCN01993 CBCN01995 CBCP01075 CBCP01085 CBCP01086 CBCP01091 CBCP01114 CBCP01772 CBCP01785 CBCP01864 CBCP02193 CBCN01917 CBCN01920 CBCN01922 CBCN01933 CBCN01936 CBCN01938 CBCN01941 CBCN01940 CBCN01942 CBCN01943 CBCP00335 CBCP00518 CBCP01216 CBCP01217 CBCP01218 CBCP01228 CBCP00574 CBCP00593 CBCP00600 CBCP00656 CBCP00658 CBCP00666 CBCP00667 CBCP00670 CBCQ00144 CBCQ00186 CBCP01222 CBCP01269 CBCP01915 CBCP01261 CBCP01536 CBCP01542 CBCP01617 CBCP01622 CBCQ00431 CBCP01189 CBCP00272 CBCP00278 CBCQ01170 CBCQ01190 CBCP01830 CBCP01898 CBCP02060 CBCP02069 CBCP02139 CBCP02140 CBCQ00604 CBCQ00611 CBCQ00612 CBCQ00622 CBCQ00623 CBCQ00624 CBCQ01191 CBCQ01201 CBCN01265 CBCN01272 CBCN01289 CBCN01291 CBCN01292 CBCN01295 CBCN01764 CBCP02159 CBCN01636 CBCN01692 CBCN01615 CBCN01590 CBCN01652 CBCN01634 CBCN01491 CBCN01553 CBCN01562 CBCN01579 CBCN01585 CBCN01592 CBCN01593 CBCN01594 CBCN01595 CBCN01596 CBCN01603 CBCN01635 CBCN01645 CBCP01464 CBCP01477 CBCP01531 CBCP02164 CBCP02179 CBCQ00242 CBCQ00633 CBCQ00699 CBCN01641 CBCN01648 CBCN01656 CBCN01659 CBCN01643 CBCN01644 CBCN01314 CBCN01315 CBCN01372 CBCN01379 CBCN01380 CBCN01374 CBCQ01320 CBCQ01322 CBCQ01323 CBCQ01324 CBCQ01325 CBCQ01326 CBCQ01327 CBCQ01328 CBCQ01329 CBCQ01330 CBCQ01255 CBCQ01272 CBCQ01276 CBCQ01278 CBCQ01283 CBCQ01285 CBCQ01286 CBCQ01290 CBCQ01291 CBCQ01292 CBCQ01293 CBCQ01295 CBCQ01299 CBCQ01301 CBCQ01309 CBCQ01310 CBCQ01316 CBCQ01336 CBCQ01343 CBCQ00713 CBCQ00886 CBCQ00892 CBCQ00893 CBCQ00894 CBCQ00895 CBCQ00896 CBCQ00897 CBCQ00898 CBCQ00899 CBCQ00900 CBCQ00901 CBCQ00902 CBCQ00903 CBCQ00904 CBCQ00905 CBCQ00906 CBCQ00907 CBCQ00908 CBCQ00909 CBCQ00910 CBCQ00911 CBCQ00912 CBCQ00913 CBCQ00914 CBCQ00915 CBCQ00916 CBCQ00917 CBCQ00918 CBCQ00923 CBCP01439 CBCP02205 CBCP00135 CBCP00246 CBCP00247 CBCP00120 CBCP00592 CBCP00614 CBCQ00345 CBCQ00346 CBCP01183 CBCP01184 CBCP01188 CBCP00144 CBCP00164 CBCP00171 CBCP01415 CBCP01452 CBCP01475 CBCP00648 CBCP01499 CBCP01972 CBCN01731 CBCP01697 CBCP01700 CBCP02147 CBCP02166 CBCP02167 CBCP01773 CBCP02165 CBCP02175 CBCQ00347 CBCQ00651 CBCQ00692 CBCN01997 CBCN01998 CBCP01811 CBCP01869 CBCP01958 CBCP01960 CBCP01975 CBCQ00111 CBCQ01347 CBCQ01363 CBCQ01383 CBCN01339 CBCN01358 CBCN01361 CBCN01404 CBCN01617 CBCN01669 CBCN01670 CBCN01680 CBCN01685 CBCQ01088 CBCQ01001 CBCQ01002 CBCP00842 CBCP00841 CBCP00847 CBCP00957 CBCP00829 CBCP00833 CBCP01362 CBCP01456 CBCP01450 CBCP01392 CBCP01257 CBCP01391 CBCP01393 CBCP01426 CBCP01431 CBCP01441 CBCP01442 CBCP01455 CBCP02146 CBCQ00350 CBCN02015 CBCN02018 CBCP01513 CBCP01413 CBCP01132 CBCQ00157 CBCQ00104 CBCP01414 CBCQ00977 CBCQ00987 CBCQ00997 CBCQ00999 CBCP00101 CBCP00103 CBCP01333 CBCP00179 CBCP00180 CBCP02145 CBCP02155 CBCP02163 CBCP02142 CBCQ00337 CBCQ00307 CBCQ00318 CBCQ00374 CBCQ00377 CBCQ00380 CBCQ00660 CBCQ00725 CBCQ00664 CBCP01666 CBCP01974 CBCP01978 CBCP01983 CBCP02044 CBCP02070 CBCP02076 CBCP02077 CBCP02078 CBCP02079 CBCP02085 CBCP02087 CBCP02090 CBCP02106 CBCP02108 CBCP02111 CBCP02112 CBCP02113 CBCP02114 CBCP02118 CBCP02137 CBCP02171 CBCP02172 CBCP02173 CBCP02174 CBCP01268 CBCQ00126 CBCP01206 CBCQ00455 CBCQ00457 CBCQ00474 CBCQ00485 CBCQ00492 CBCQ00503 CBCQ00280 CBCQ00439 CBCQ00533 CBCQ00535 CBCN01393 CBCN01477 CBCP00794 CBCN01975 CBCP00956 CBCQ01157 CBCN01192 CBCN01523 CBCN01530 CBCN01531 CBCN01538 CBCN01539 CBCN01563 CBCN01542 CBCP00589 CBCP00597 CBCP00607 CBCP00610 CBCP00611 CBCP00613 CBCP00616 CBCP00617 CBCP00637 CBCP00686 CBCP01846 CBCP01854 CBCP01855 CBCP01856 CBCP01872 CBCP01833 CBCP01847 CBCP01857 CBCP01862 CBCP01880 CBCP01881 CBCP01887 CBCP01888 CBCP01890 CBCP01892 CBCQ00989 CBCQ00993 CBCQ00995 CBCQ00996 CBCQ01000 CBCN01961 CBCN01962 CBCP00945 CBCP00955 CBCP01049 CBCP01063 CBCP01064 CBCP01065 CBCP01066 CBCP01067 CBCP01068 CBCQ00499 CBCN01328 CBCN01329 CBCN01335 CBCN01341 CBCN01343 CBCN01696 CBCN01702 CBCN01725 CBCN01726 CBCN01756 CBCN01952 CBCP00114 CBCN01950 CBCP00132 CBCN01999 CBCN02003 CBCN01954 CBCP00186 CBCP00184 CBCP00211 CBCP00213 CBCP00573 CBCP00583 CBCP00558 CBCP00529 CBCP00538 CBCP00751 CBCP00789 CBCP00790 CBCP00791 CBCP00792 CBCP00687 CBCP00918 CBCP00919 CBCP01162 CBCP01117 CBCP01119 CBCP01131 CBCP01229 CBCP01199 CBCP01182 CBCP01191 CBCP01198 CBCP01821 CBCP01908 CBCP01987 CBCP02256 CBCP02268 CBCP02275 CBCP02277 CBCP02282 CBCP02283 CBCP02285 CBCQ00608 CBCQ00712 CBCQ01074 CBCQ01078 CBCQ01080 CBCQ01082 CBCQ01099 CBCP00274 CBCP00285 CBCP00653 CBCP01209 CBCP01395 CBCP01566 CBCP01567 CBCP01663 CBCP01664 CBCP01667 CBCP01669 CBCP01675 CBCP01701 CBCP01702 CBCP01705 CBCP01706 CBCP01707 CBCP01711 CBCP01712 CBCP01713 CBCP01714 CBCP01715 CBCP01716 CBCP01717 CBCP01718 CBCP01719 CBCP01720 CBCP01722 CBCP00200 CBCP00201 CBCP00202 CBCP00204 CBCP00205 CBCP00206 CBCP00208 CBCP00200 CBCP00201 CBCP00202 CBCP00204 CBCP00205 CBCP00206 CBCP00208 CBCP01970 CBCP01971 CBCP01969 CBCP01625 CBCP01831 CBCP01959 CBCP01959 CBCN01179 CBCN01180 CBCN01181 CBCN01182 CBCN01183 CBCP00121 CBCP00313 CBCP00387 CBCP00632 CBCP00692 CBCP00694 CBCP00696 CBCP00697 CBCP00698 CBCP00699 CBCP00700 CBCP00701 CBCP00704 CBCP00705 CBCP00707 CBCP00708 CBCP00709 CBCP00712 CBCP00720 CBCP00721 CBCP00722 CBCP00723 CBCP00724 CBCP00725 CBCP00726 CBCP00727 CBCP00730 CBCP00731 CBCP01544 CBCP01245 CBCQ00588 CBCP01115 CBCN01174 CBCN01175 CBCN01176 CBCN01177 CBCN01080 CBCN01155 CBCN01156 CBCN01158 CBCN01159 CBCN01160 CBCN01161 CBCN01162 CBCN01312 CBCN01318 CBCN01300 CBCN01302 CBCN01305 CBCN01309 CBCN01310 CBCN01320 CBCN01708 CBCN01710 CBCN01698 CBCN01703 CBCN01697 CBCN01709 CBCN01736 CBCN01717 CBCN01734 CBCN01699 CBCP00107 CBCP00108 CBCP00111 CBCP00113 CBCP00146 CBCP00149 CBCP00321 CBCP00328 CBCP00329 CBCP00330 CBCP00304 CBCP00308 CBCP00311 CBCP00315 CBCP00318 CBCP00323 CBCP00341 CBCP00365 CBCP00228 CBCP00267 CBCP00333 CBCP00352 CBCP00388 CBCP00404 CBCP00526 CBCP00530 CBCP00564 CBCP00576 CBCP00579 CBCP00636 CBCP00650 CBCP00638 CBCP00639 CBCP00640 CBCP00766 CBCP00773 CBCP00786 CBCP00799 CBCP00821 CBCP00922 CBCP00926 CBCP00933 CBCP00934 CBCP00940 CBCP00986 CBCP00987 CBCP00988 CBCP00989 CBCP00990 CBCP00991 CBCP00992 CBCP00993 CBCP00994 CBCP00995 CBCP00996 CBCP00997 CBCP00915 CBCP00931 CBCP00935 CBCP00999 CBCP00958 CBCP00960 CBCP00998 CBCP01123 CBCP01146 CBCP01185 CBCP00929 CBCP01247 CBCP01256 CBCP01259 CBCP01270 CBCP01310 CBCP01343 CBCP01552 CBCP01347 CBCP01448 CBCP01495 CBCP01492 CBCP01573 CBCP02181 CBCP02185 CBCP02250 CBCQ00145 CBCQ00226 CBCQ00229 CBCQ00292 CBCQ00294 CBCQ00298 CBCQ00477 CBCQ00483 CBCQ00491 CBCQ00495 CBCQ00498 CBCQ01093 CBCQ01097 CBCQ01265 CBCQ01275 CBCQ01288 CBCQ01315 CBCQ01318 SO-5262817 CBCP00129 CBCP00153 CBCP00154 CBCP00169 CBCP00174 CBCP00196 CBCP00197 CBCN01786 CBCN01771 CBCN01810 CBCN01812 CBCN01818 CBCP00143 CBCP00185 CBCP00193 CBCP00294 CBCP00376 CBCP00377 CBCP00378 CBCP00379 CBCP00381 CBCP00282 CBCP00292 CBCP00398 CBCP00505 CBCP00508 CBCP00572 CBCP00828 CBCP00838 CBCP01089 CBCP01096 CBCP01100 CBCP01102 CBCP01112 CBCP01113 CBCP01020 CBCP01022 CBCP01235 CBCP01251 CBCP01253 CBCP01260 CBCP01376 CBCP01378 CBCP01344 CBCP01385 CBCP01487 CBCP01317 CBCP01517 CBCP01292 CBCP01549 CBCP01699 CBCP01695 CBCP01738 CBCP01743 CBCP01558 CBCP01769 CBCP01850 CBCP01860 CBCP01808 CBCP01853 CBCP01949 CBCP01950 CBCP01951 CBCP01827 CBCP01829 CBCP01865 CBCP01834 CBCP01835 CBCP01836 CBCP01845 CBCP01947 CBCP02138 CBCP02210 CBCP02207 CBCP02216 CBCP02203 CBCP02204 CBCP02213 CBCP02219 CBCP02220 CBCP02263 CBCP02262 CBCP01776 CBCP02092 CBCQ00339 CBCQ00348 CBCQ00388 CBCQ00397 CBCQ00425 CBCQ00252 CBCQ00581 CBCQ00590 CBCQ00683 CBCQ00693 CBCQ00241 CBCQ00266 CBCQ00301 CBCQ00599 CBCQ00246 CBCQ00325 CBCQ00747 CBCQ00952 CBCQ00953 CBCQ00954 CBCQ00955 CBCQ01091 CBCQ01094 CBCQ01095 CBCQ01096 CBCQ01238 CBCQ01263 CBCQ01269 CBCQ01273 CBCQ01259 CBCQ01260 CBCQ01264 CBCQ01266 CBCQ01271 CBCQ01274 CBCQ01277 CBCQ01317 CBCN01580 CBCN01640 CBCN01646 CBCQ01017 CBCQ01019 CBCQ01026 CBCQ01027 CBCQ01032 CBCP00457 CBCP00551 CBCP00563 CBCP00565 CBCQ00351…

Recall started

Jan. 27, 2015

Device type

Ventilator, Continuous, Facility Use

Root cause (FDA)

Device Design

What the company told customers

GE Healthcare sent an Urgent Medical Device Correction letter dated January 26, 2015, Ref#34063. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171, or your local Service Representative.

Recall number

Z-1270-2015

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

Source: FDA · Medical device enforcement report, recall number Z-1270-2015. The agency record governs; check it and the company before acting.