Retiro De Equipo (Recall) de Device Recall GE Healthcare Engstrom Carestation and Engstrom Pro

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por GE Healthcare.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    70443
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1270-2015
  • Fecha de inicio del evento
    2015-01-27
  • Fecha de publicación del evento
    2015-03-24
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2016-02-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Ventilator, continuous, facility use - Product Code CBK
  • Causa
    Potential failure of the caster mounting hardware, which may result in the ventilator falling/tipping (overbalancing).
  • Acción
    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.

Device

  • Modelo / Serial
    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 CBCN0159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3 CBCP01594 CBCP01595 CBCP01596 CBCP01597 CBCP01598 CBCP01599 CBCP01607 CBCP01608 CBCP01609 CBCP01610 CBCP01611 CBCP01612 CBCP01614 CBCP01668 CBCP01673 CBCP01676 CBCP01681 CBCP01468 CBCP01472 CBCP01474 CBCP01482 CBCP01483 CBCP01508 CBCP01510 CBCP01516 CBCP01525 CBCP01534 CBCP01551 CBCP01556 CBCP01557 CBCP01797 CBCP01798 CBCP01803 CBCP01804 CBCP01807 CBCP01849 CBCP01858 CBCP01863 CBCP01868 CBCP01871 CBCP01876 CBCP01882 CBCP01883 CBCP01884 CBCP01889 CBCP01891 CBCP01893 CBCP01896 CBCP01899 CBCP01900 CBCP01901 CBCP01902 CBCP01904 CBCP01906 CBCP01913 CBCP01920 CBCP01921 CBCP01922 CBCP01924 CBCP01936 CBCP01937 CBCP01938 CBCP01939 CBCP01940 CBCP01942 CBCP01943 CBCP01944 CBCP01945 CBCP01946 CBCP01948 CBCP01912 CBCP01989 CBCP02260 CBCP02249 CBCP02265 CBCP02267 CBCP02135 CBCP02143 CBCP02153 CBCP02158 CBCP02160 CBCP02161 CBCP02230 CBCP02235 CBCP02236 CBCP02237 CBCP02238 CBCP02239 CBCP02240 CBCP02241 CBCP02242 CBCP02244 CBCP02245 CBCP02246 CBCP02247 CBCP02183 CBCP02189 CBCP02224 CBCP02225 CBCP02254 CBCP02257 CBCP02259 CBCP02264 CBCP02266 CBCP02272 CBCP02187 CBCP02197 CBCP02208 CBCP02228 CBCP02229 CBCP02251 CBCP02221 CBCP02252 CBCQ00110 CBCP01274 CBCP01980 CBCP02084 CBCP02117 CBCP02218 CBCQ00355 CBCQ00362 CBCQ00367 CBCQ00543 CBCQ00803 CBCQ01192 CBCQ01196 CBCQ01210 CBCQ01213 CBCQ01221 CBCQ01225 CBCQ01226 CBCQ01227 CBCQ01235 CBCQ00704 CBCQ00705 CBCQ00802 CBCQ01130 CBCQ01155 CBCQ01340 CBCP00594 CBCP00615 CBCP00628 CBCP00629 CBCP00630 CBCP00642 CBCP00643 CBCP00644 CBCP00661 CBCP00665 CBCP00669 CBCP00742 CBCP00748 CBCP00760 CBCP00767 CBCP00771 CBCP00772 CBCP00774 CBCP00780 CBCQ00424 CBCP01440 CBCN01814 CBCN01816 CBCN01822 CBCN01823 CBCN01824 CBCN01825 CBCN01826 CBCN01827 CBCN01828 CBCN01829 CBCP00408 CBCP00467 CBCP00471 CBCP00475 CBCP00458 CBCP00459 CBCP00460 CBCP00462 CBCN01830 CBCN01831 CBCN01832 CBCN01833 CBCN01433 CBCN01783 CBCN01785 CBCN01811 CBCP00453 CBCP00456 CBCP00464 CBCP00466 CBCP00469 CBCP00474 CBCP00973 CBCP00974 CBCP00976 CBCP00977 CBCP01604 CBCP01616 CBCP01877 CBCP01923 CBCP01931 CBCP01932 CBCP01929 CBCP02178 CBCP02186 CBCP01278 CBCQ00426 CBCQ00315 CBCQ00695 CBCQ00673 CBCN01434 CBCN01540 CBCN01541 CBCN01544 CBCN01547 CBCN01549 CBCN01551 CBCN01552 CBCN01555 CBCN01558 CBCN01560 CBCN01572 CBCN01373 CBCN01550 CBCN01557 CBCN01564 CBCN01567 CBCN01604 CBCN01910 CBCN01973 CBCN02000 CBCN02008 CBCN02016 CBCN01948 CBCN01988 CBCN01994 CBCN01996 CBCN01872 CBCN01905 CBCN01912 CBCN01960 CBCN02009 CBCN02010 CBCN02011 CBCN02012 CBCN02013 CBCN02014 CBCN02000 CBCQ00512 CBCQ00951 SO-5273986 SO-10506453 CBCN01573 CBCN01677 CBCN01687 CBCN01689 CBCN01691 CBCN01693 CBCN01690 CBCN01723 CBCN01728 CBCN01951 CBCN01953 CBCN01955 CBCN01956 CBCN01958 CBCN01959 CBCN01966 CBCN01976 CBCN01977 CBCN01978 CBCN01979 CBCN01987 CBCP00100 CBCP00102 CBCP00104 CBCP00105 CBCP00109 CBCP00110 CBCP00112 CBCP00115 CBCP00117 CBCP00118 CBCP00116 CBCP00155 CBCP00157 CBCP00172 CBCP00173 CBCP00163 CBCP00168 CBCP00264 CBCP00255 CBCP00260 CBCP00210 CBCP00219 CBCP00222 CBCP00924 CBCP00925 CBCP00896 CBCP00923 CBCP00962 CBCP00911 CBCP00917 CBCP00928 CBCP00930 CBCP00936 CBCP00937 CBCP00959 CBCP00941 CBCP00944 CBCP00984 CBCP00826 CBCP00972 CBCP00979 CBCP00980 CBCP01004 CBCP01005 CBCP01006 CBCP01007 CBCP01008 CBCP01009 CBCP01010 CBCP01011 CBCP01045 CBCP01052 CBCP00927 CBCP00932 CBCP00938 CBCP00939 CBCP01017 CBCP01101 CBCP01111 CBCP01370 CBCP01374 CBCP01375 CBCP01381 CBCP01382 CBCP01389 CBCP01373 CBCP01600 CBCP01605 CBCP01927 CBCP01928 CBCP01839 CBCP02072 CBCP02258 CBCP02068 CBCQ00154 CBCQ00156 CBCQ00174 CBCQ00170 CBCQ00173 CBCQ00235 CBCQ00236 CBCQ00237 CBCP01207 CBCP02101 CBCP02120 CBCQ00153 CBCQ00158 CBCQ00159 CBCQ00166 CBCQ00167 CBCQ00168 CBCQ00169 CBCQ00171 CBCQ00172 CBCQ00175 CBCP01778 CBCP02119 CBCP01762 CBCP02091 CBCP02217 CBCP02243 CBCP02261 CBCQ00114 CBCQ00123 CBCQ00147 CBCQ00149 CBCQ00150 CBCQ00221 CBCQ00223 CBCQ00106 CBCQ00109 CBCQ00222 CBCQ00231 CBCQ00232 CBCQ00248 CBCQ00262 CBCQ00267 CBCP01822 CBCP01990 CBCQ00381 CBCQ00382 CBCQ00101 CBCQ00102 CBCQ00199 CBCQ00379 CBCQ00373 CBCQ00398 CBCQ00178 CBCQ00316 CBCQ00317 CBCQ00323 CBCQ00328 CBCQ00402 CBCQ00394 CBCQ00400 CBCQ00401 CBCQ00432 CBCQ00461 CBCQ00462 CBCQ00463 CBCQ00464 CBCQ00465 CBCQ00466 CBCQ00332 CBCQ00340 CBCQ00341 CBCQ00395 CBCQ00417 CBCQ00308 CBCQ00336 CBCQ00383 CBCQ00384 CBCQ00393 CBCQ00403 CBCQ00404 CBCQ00405 CBCQ00416 CBCQ00544 CBCQ00545 CBCQ00573 CBCQ00538 CBCQ00542 CBCQ00547 CBCQ00548 CBCQ00521 CBCQ00526 CBCQ00430 CBCQ00436 CBCQ00441 CBCQ00447 CBCQ00449 CBCQ00451 CBCQ00452 CBCQ00453 CBCQ00454 CBCQ00486 CBCQ00531 CBCQ00321 CBCQ00322 CBCQ00407 CBCQ00418 CBCQ00427 CBCQ00571 CBCQ00584 CBCQ00506 CBCQ00516 CBCQ00518 CBCQ00536 CBCQ00540 CBCQ00541 CBCQ00549 CBCQ00553 CBCQ00560 CBCQ00561 CBCQ00562 CBCQ00563 CBCQ00564 CBCQ00565 CBCQ00567 CBCQ00568 CBCQ00572 CBCQ00574 CBCQ00575 CBCQ00579 CBCQ00585 CBCQ00586 CBCQ00589 CBCQ00591 CBCQ00594 CBCQ00597 CBCQ00602 CBCQ00661 CBCQ00629 CBCQ00637 CBCQ00644 CBCQ00649 CBCQ00675 CBCQ00652 CBCQ00677 CBCQ00618 CBCQ00642 CBCQ00676 CBCQ00680 CBCQ00715 CBCQ00804 CBCQ00805 CBCQ00806 CBCQ00807 CBCQ00809 CBCQ00811 CBCQ00815 CBCQ00816 CBCQ00659 CBCQ00688 CBCQ00992 CBCQ01077 CBCQ01086 CBCQ01100 CBCQ01039 CBCQ01106 CBCQ01107 CBCQ01108 CBCQ01109 CBCQ01110 CBCN01301 CBCN01311 CBCN01313 CBCN01317 CBCN01319 CBCN01322 CBCN01323 CBCN01333 CBCN01321 CBCN01324 CBCP00729 CBCP00738 CBCQ00939 CBCQ00943 CBCQ00947 CBCQ00956 CBCQ00971 CBCQ00978 CBCQ00979 CBCQ00980 CBCQ00981 CBCQ00982 CBCQ01030 CBCN01148 CBCN01294 CBCN01297 CBCN01609 CBCN01633 CBCN01657 CBCN01664 CBCN01672 CBCN01688 CBCN01658 CBCN01757 CBCN01758 CBCN01767 CBCN01770 CBCP00271 CBCP00291 CBCP00298 CBCP00322 CBCP00334 CBCP00344 CBCP00302 CBCP00367 CBCP00415 CBCP00421 CBCP00422 CBCP00483 CBCP00496 CBCP00499 CBCP00502 CBCP00503 CBCP00504 CBCP00506 CBCP00514 CBCP00516 CBCP00521 CBCP00525 CBCP00562 CBCP00951 SO-10701818 CBCN01350 CBCN01435 CBCN01483 CBCP01326 CBCP01340 CBCP01335 CBCP01336 CBCP01363 CBCQ00994 CBCP01368 CBCP01781 CBCP01792 CBCQ00113 CBCQ00269 CBCQ00273 CBCQ00582 CBCQ00628 CBCQ00679 CBCN01815 CBCP00214 CBCP00215 CBCP00216 CBCP00218 CBCP01329 CBCP01334 CBCP01874 CBCP01878 CBCP01925 CBCP01926 CBCP01933 CBCP01934 CBCP01935 CBCN01293 CBCN01303 CBCN01345 CBCN01349 CBCN01360 CBCN01365 CBCN01378 CBCN01518 CBCN01836 CBCN01857 CBCN01913 CBCN01916 CBCN01586
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA