Events

Retiro De Equipo (Recall) de Device Recall GE DatexOhmeda Aisys CS2 Anesthesia System

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 Medical Systems, LLC.

¿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
    73617
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1562-2016
  • Fecha de inicio del evento
    2016-03-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144608
  • 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
    Gas-machine, anesthesia - Product Code BSZ
  • Causa
    The vacuum suction tubing could be kinked within the machine resulting in suction less than the 20 lpm required by iso 10079-3. this could result in inadequate suction performance to clear the airway and inadequate ventilation of the patient.
  • Acción
    Consignees were sent a GE Healthcare "Urgent Medical Device Correction" GEHC Ref# 34076 letter, dated March 15, 2016. The letter was addressed to the Chief of Anesthesia / Health Care Administrator / Risk Manager and Director of Biomedical / Clinical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The letter states that users can continue to use all functions of the device. However, the vacuum suction option can only be used if it passes the evaluation. A GE representative will contact customers to arrange for the correction at no cost to the customer. For questions or concerns regarding this notification, contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

Device Recall GE DatexOhmeda Aisys CS2 Anesthesia System
  • Modelo / Serial
    Mfg Lot or Serial # UDI IDENTIFIER APWU00723 not applicable APWU00724 not applicable APWU01988 010084068210229221APWU0198811150921 APWU01989 010084068210229221APWU0198911150921 APWU01990 010084068210229221APWU0199011150921 APWU01991 010084068210229221APWU0199111150921 APWU01992 010084068210229221APWU0199211150921 APWU01993 010084068210229221APWU0199311150921 APWU01994 010084068210229221APWU0199411150921 APWU01995 010084068210229221APWU0199511150921 APWU01996 010084068210229221APWU0199611150921 APWU01997 010084068210229221APWU0199711150921 APWU00707 not applicable APWU00708 not applicable APWU00709 not applicable APWU00710 not applicable APWU00711 not applicable APWU02166 010084068210229221APWU0216611151014 APWU02170 010084068210229221APWU0217011151014 APWU02171 010084068210229221APWU0217111151014 APWU02172 010084068210229221APWU0217211151014 APWU00712 not applicable APWU00505 not applicable APWU00506 not applicable APWU00507 not applicable APWU00474 not applicable APWU00475 not applicable APWU00476 not applicable APWU00477 not applicable APWU00478 not applicable APWU00479 not applicable APWU01486 not applicable APWU01487 not applicable APWU01488 not applicable APWU01489 not applicable APWU01490 not applicable APWU01491 not applicable APWU01492 not applicable APWU01493 not applicable APWU01494 not applicable APWU01495 not applicable APWU00611 not applicable APWU00612 not applicable APWU00613 not applicable APWU00614 not applicable APWU02163 010084068210229221APWU0216311151014 APWU02164 010084068210229221APWU0216411151014 APWU02165 010084068210229221APWU0216511151014 APWU02051 010084068210229221APWU0205111151002 APWU01909 010084068210229221APWU0190911150902 APWU02017 010084068210229221APWU0201711150921 APWU02018 010084068210229221APWU0201811150921 APWU00297 not applicable APWU01608 not applicable APWU01609 not applicable APWU01610 not applicable APWU01611 not applicable APWU01612 not applicable APWU01613 not applicable APWU01614 not applicable APWU01615 not applicable APWU00579 not applicable APWU00580 not applicable APWU00581 not applicable APWU00582 not applicable APWU00583 not applicable APWU00584 not applicable APWU00585 not applicable APWU00586 not applicable APWU00587 not applicable APWU00588 not applicable APWU00589 not applicable APWU00590 not applicable APWU00591 not applicable APWU00592 not applicable APWU00593 not applicable APWU00594 not applicable APWU00595 not applicable APWU00596 not applicable APWU00597 not applicable APWU00598 not applicable APWU00599 not applicable APWU00600 not applicable APWU00601 not applicable APWU00602 not applicable APWU00603 not applicable APWU00728 not applicable APWU00729 not applicable APWU00730 not applicable APWU00751 not applicable APWU00752 not applicable APWU00753 not applicable APWU00754 not applicable APWU00755 not applicable APWU00604 not applicable APWU00605 not applicable APWU00606 not applicable APWU00713 not applicable APWU01410 not applicable APWU01411 not applicable APWU01412 not applicable APWU02108 010084068210229221APWU0210811151007 APWU00293 not applicable APWU00260 not applicable APWU01616 not applicable APWU01617 not applicable APWU01618 not applicable APWU01619 not applicable APWU01620 not applicable APWU01621 not applicable APWU01622 not applicable APWU01623 not applicable APWU01699 not applicable APWU01700 not applicable APWU01701 not applicable APWU01702 not applicable APWU01703 not applicable APWU01704 not applicable APWU01705 not applicable APWU01706 not applicable APWU01707 not applicable APWU01708 not applicable APWU01709 not applicable APWU01710 not applicable APWU01652 not applicable APWU01653 not applicable APWU01654 not applicable APWU01655 not applicable APWU01096 not applicable APWU01097 not applicable APWU01098 not applicable APWU01099 not applicable APWU01100 not applicable APWU01101 not applicable APWU01102 not applicable APWU01103 not applicable APWU01104 not applicable APWU01105 not applicable APWU01106 not applicable APWU01107 not applicable APWU01108 not applicable APWU01109 not applicable APWU01736 not applicable APWU01737 not applicable APWU00864 not applicable APWU00865 not applicable APWU00866 not applicable APWU00867 not applicable APWU00868 not applicable APWU00869 not applicable APWU00870 not applicable APWU00871 not applicable APWU00607 not applicable APWU00608 not applicable APWU00610 not applicable APWU02176 010084068210229221APWU0217611151014 APWU01910 010084068210229221APWU0191011150902 APWU00913 not applicable APWU01911 010084068210229221APWU0191111150902 APWU01912 010084068210229221APWU0191211150902 APWU01913 010084068210229221APWU0191311150902 APWU01914 010084068210229221APWU0191411150902 APWU01929 010084068210229221APWU0192911150917 APWU01930 010084068210229221APWU0193011150917 APWU01931 010084068210229221APWU0193111150917 APWU01932 010084068210229221APWU0193211150917 APWU01933 010084068210229221APWU0193311150917 APWU01934 010084068210229221APWU0193411150917 APWU01935 010084068210229221APWU0193511150917 APWU01936 010084068210229221APWU0193611150917 APWU01937 010084068210229221APWU0193711150917 APWU01938 010084068210229221APWU0193811150917 APWU00764 not applicable APWU00765 not applicable APWU00766 not applicable APWU00889 not applicable APWU01443 not applicable APWU01444 not applicable APWU01445 not applicable APWU01446 not applicable APWU01447 not applicable APWU01448 not applicable APWU01449 not applicable APWU01450 not applicable APWU01451 not applicable APWU01452 not applicable APWU00725 not applicable APWU00726 not applicable APWU00727 not applicable APWU00241 not applicable APWU00242 not applicable APWU00243 not applicable APWU00244 not applicable APWU00245 not applicable APWU00486 not applicable APWU00487 not applicable APWU01665 not applicable APWU01666 not applicable APWU01667 not applicable APWU01668 not applicable APWU01669 not applicable APWU01670 not applicable APWU01671 not applicable APWU01672 not applicable APWU01673 not applicable APWU01674 not applicable APWU01675 not applicable APWU01684 not applicable APWU01685 not applicable APWU01686 not applicable APWU01687 not applicable APWU01688 not applicable APWU01689 not applicable APWU01690 not applicable APWU01691 not applicable APWU01692 not applicable APWU01693 not applicable APWU01694 not applicable APWU01540 not applicable APWU01541 not applicable APWU01542 not applicable APWU01543 not applicable APWU01544 not applicable APWU01545 not applicable APWU01546 not applicable APWU01547 not applicable APWU01548 not applicable APWU01549 not applicable APWU01560 not applicable APWU01561 not applicable APWU01562 not applicable APWU01563 not applicable APWU01564 not applicable APWU01565 not applicable APWU01566 not applicable APWU01567 not applicable APWU01568 not applicable APWU01569 not applicable APWU01570 not applicable APWU00937 not applicable APWU00938 not applicable APWU02053 010084068210229221APWU0205311151002 APWU02054 010084068210229221APWU0205411151002 APWU02055 010084068210229221APWU0205511151002 APWU02056 010084068210229221APWU0205611151002 APWU02057 010084068210229221APWU0205711151002 APWU02058 010084068210229221APWU0205811151002 APWU00540 not applicable APWU00541 not applicable APWU00542 not applicable APWU00543 not applicable APWU00621 not applicable APWU00622 not applicable APWU00623 not applicable APWU00624 not applicable APWU00625 not applicable APWU00626 not applicable APWU00627 not applicable APWU00628 not applicable APWU00629 not applicable APWU00630 not applicable APWU00631 not applicable APWU00632 not applicable APWU00633 not applicable APWU00634 not applicable APWU00635 not applicable APWU00636 not applicable APWU00637 not applicable APWU00638 not applicable APWU00639 not applicable APWU00645 not applicable APWU00646 not applicable APWU00647 not applicable APWU00648 not applicable APWU00649 not applicable APWU00650 not applicable APWU00651 not applicable APWU00652 not applicable APWU00653 not applicable APWU00654 not applicable APWU00655 not applicable APWU00656 not applicable APWU00657 not applicable APWU00658 not applicable APWU00659 not applicable APWU00660 not applicable APWU00661 not applicable APWU00662 not applicable APWU00663 not applicable APWU00664 not applicable APWU00665 not applicable APWU00666 not applicable APWU00667 not applicable APWU00668 not applicable APWU00669 not applicable APWU00670 not applicable APWU00671 not applicable APWU00672 not applicable APWU00673 not applicable APWU00674 not applicable APWU00675 not applicable APWU00676 not applicable APWU00677 not applicable APWU00678 not applicable APWU00250 not applicable APWU00252 not applicable APWU00517 not applicable APWU00519 not applicable APWU00520 not applicable APWU00524 not applicable APWU00274 not applicable APWU00275 not applicable APWU00276 not applicable APWU00277 not applicable APWU00278 not applicable APWU00279 not applicable APWU00280 not applicable APWU00281 not applicable APWU00282 not applicable APWU00283 not applicable APWU00284 not applicable APWU00285 not applicable APWU00286 not applicable APWU00287 not applicable APWU00288 not applicable APWU00289 not applicable APWU00290 not applicable APWU00291 not applicable APWU00292 not applicable APWU01360 not applicable APWU01361 not applicable APWU01362 not applicable APWU01363 not applicable APWU01364 not applicable APWU01365 not applicable APWU01366 not applicable APWU01367 not applicable APWU01368 not applicable APWU01369 not applicable APWU01370 not applicable APWU00485 not applicable APWU01348 not applicable APWU01349 not applicable APWU01350 not applicable APWU01351 not applicable APWU01352 not applicable APWU01353 not applicable APWU01354 not applicable APWU01355 not applicable APWU01356 not applicable APWU01357 not applicable APWU01358 not applicable APWU01331 not applicable APWU01332 not applicable APWU01333 not applicable APWU01334 not applicable APWU01335 not applicable APWU01336 not applicable APWU01337 not applicable APWU01338 not applicable APWU00208 not applicable APWU00529 not applicable APWU00530 not applicable APWU00531 not applicable APWU00532 not applicable APWU00533 not applicable APWU00756 not applicable APWU00757 not applicable APWU00758 not applicable APWU00759 not applicable APWU00760 not applicable APWU00761 not applicable APWU00762 not applicable APWU00763 not applicable APWU02115 010084068210229221APWU0211511151007 APWU02116 010084068210229221APWU0211611151007 APWU02117 010084068210229221APWU0211711151007 APWU02118 010084068210229221APWU0211811151007 APWU02119 010084068210229221APWU0211911151007 APWU02120 010084068210229221APWU0212011151007 APWU02121 010084068210229221APWU0212111151014 APWU02122 010084068210229221APWU0212211151014 APWU02123 010084068210229221APWU0212311151014 APWU02124 010084068210229221APWU0212411151014 APWU02125 010084068210229221APWU0212511151014 APWU02126 010084068210229221APWU0212611151014 APWU02127 010084068210229221APWU0212711151014 APWU02128 010084068210229221APWU0212811151014 APWU02129 010084068210229221APWU0212911151014 APWU02130 010084068210229221APWU0213011151014 APWU02131 010084068210229221APWU0213111151014 APWU02132 010084068210229221APWU0213211151014 APWU02133 010084068210229221APWU0213311151014 APWU02134 010084068210229221APWU0213411151014 APWU02135 010084068210229221APWU0213511151014 APWU01681 not applicable APWU01682 not applicable APWU01683 not applicable APWU01924 010084068210229221APWU0192411150917 APWU01925 010084068210229221APWU0192511150917 APWU01926 010084068210229221APWU0192611150917 APWU01927 010084068210229221APWU0192711150917 APWU02104 010084068210229221APWU0210411151007 APWU01939 010084068210229221APWU0193911150917 APWU01940 010084068210229221APWU0194011150917 APWU01941 010084068210229221APWU0194111150918 APWU01942 010084068210229221APWU0194211150918 APWU01943 010084068210229221APWU0194311150918 APWU02105 010084068210229221APWU0210511151007 APWU02106 010084068210229221APWU0210611151007 APWU02107 010084068210229221APWU0210711151007 APWU02177 010084068210229221APWU0217711151014 APWU02178 010084068210229221APWU0217811151014 APWU01676 not applicable APWU00509 not applicable APWU00510 not applicable APWU00511 not applicable APWU00512 not applicable APWU00990 not applicable APWU00991 not applicable APWU00992 not applicable APWU00993 not applicable APWU00994 not applicable APWU00995 not applicable APWU00996 not applicable APWU00997 not applicable APWU00998 not applicable APWU00999 not applicable APWU00714 not applicable APWU00715 not applicable APWU00716 not applicable APWU00717 not applicable APWU00718 not applicable APWU00294 not applicable APWU00508 not applicable ANAU00102 not applicable ANAU00103 not applicable APWU02329 010084068210229221APWU0232911151103 APWU00973 010084068210229221APWU0097311150511 APWU00975 010084068210229221APWU0097511150511 APWU00976 010084068210229221APWU0097611150511 APWU00980 010084068210229221APWU0098011150511 APWU00480 not applicable APWU00481 not applicable APWU00482 not applicable APWU00483 not applicable APWU00484 not applicable APWU00352 not applicable APWU00972 010084068210229221APWU0097211150511 APWU00974 010084068210229221APWU0097411150511 APWU00977 010084068210229221APWU0097711150511 APWU00978 010084068210229221APWU0097811150511 APWU00979 010084068210229221APWU0097911150511 APWU00981 010084068210229221APWU0098111150511 APWU00251 not applicable APWU00912 not applicable APWU00513 not applicable APWU00514 not applicable APWU00558 not applicable APWU00246 not applicable APWU02109 010084068210229221APWU0210911151007 APWU01000 not applicable APWU01001 not applicable APWU01002 not applicable APWU01003 not applicable APWU01004 not applicable APWU01005 not applicable APWU01006 not applicable APWU01007 not applicable APWU01008 not applicable APWU01009 not applicable APWU01010 not applicable APWU01011 not applicable APWU01371 010084068210229221APWU0137111150624 APWU01372 010084068210229221APWU0137211150624 APWU01373 010084068210229221APWU0137311150624 APWU01374 010084068210229221APWU0137411150624 APWU01375 010084068210229221APWU0137511150624 APWU01376 010084068210229221APWU0137611150624 APWU00722 not applicable APWU01436 not applicable APWU01437 not applicable APWU01438 not applicable APWU01439 not applicable APWU01440 not applicable APWU01441 not applicable APWU01442 not applicable APWU00557 not applicable APWU02030 010084068210229221APWU0203011150929 APWU02031 010084068210229221APWU0203111150929 APWU02072 010084068210229221APWU0207211151002 APWU02073 010084068210229221APWU0207311151002 APWU02074 010084068210229221APWU0207411151002 APWU02075 010084068210229221APWU0207511151002 APWU02159 010084068210229221APWU0215911151014 APWU02160 010084068210229221APWU0216011151014 APWU02161 010084068210229221APWU0216111151014 APWU02162 010084068210229221APWU0216211151014 APWU02332 010084068210229221APWU0233211151103 APWU01679 not applicable APWU00806 not applicable APWU00807 not applicable APWU00808 not applicable APWU00809 not applicable APWU00810 not applicable APWU00811 not applicable APWU00812 not applicable APWU00813 not applicable APWU00814 not applicable APWU00815 not applicable APWU00816 not applicable APWU00817 not applicable APWU01805 010084068210229221APWU0180511150819 APWU01799 010084068210229221APWU0179911150819 APWU00884 not applicable APWU00172 not applicable APWU00173 not applicable APWU00174 not applicable APWU00488 not applicable APWU00489 not applicable APWU00490 not applicable APWU00491 not applicable APWU00492 not applicable APWU00493 not applicable APWU00494 not applicable APWU00495 not applicable APWU00496 not applicable APWU00313 not applicable APWU00914 not applicable APWU00898 not applicable APWU00872 not applicable APWU00873 not applicable APWU00874 not applicable APWU00915 not applicable APWU00836 not applicable APWU00370 not applicable APWU00371 not applicable APWU00307 not applicable APWU00412 not applicable APWU00464 not applicable APWU00465 not applicable APWU00466 not applicable APWU00467 not applicable APWU00468 not applicable APWU00469 not applicable APWU00470 not applicable APWU00471 not applicable APWU00472 not applicable APWU00473 not applicable APWU02039 010084068210229221APWU0203911150929 APWU00319 not applicable APWU00320 not applicable APWU00321 not applicable APWU00322 not applicable APWU00323 not applicable APWU00840 not applicable APWU00841 not applicable APWU00842 not applicable APWU00843 not applicable APWU00844 not applicable APWU00845 not applicable APWU00846 not applicable APWU00847 not applicable APWU00247 not applicable APWU00936 not applicable APWU00211 not applicable APWU00212 not applicable APWU00213 not applicable APWU00214 not applicable APWU01761 010084068210229221APWU0176111150819 APWU01762 010084068210229221APWU0176211150819 APWU01763 010084068210229221APWU0176311150819 APWU01764 010084068210229221APWU0176411150819 APWU01765 010084068210229221APWU0176511150819 APWU01766 010084068210229221APWU0176611150819 APWU00891 not applicable APWU00892 not applicable APWU00343 not applicable APWU00933 not applicable APWU00935 not applicable APWU01220 not applicable APWU01221 not applicable APWU01222 not applicable APWU01223 not applicable APWU01224 not applicable APWU01225 not applicable APWU01226 not applicable APWU01227 not applicable APWU01228 not applicable APWU01229 not applicable APWU01230 not applicable APWU01231 not applicable APWU01232 not applicable APWU01233 not applicable APWU01234 not applicable APWU01235 not applicable APWU01236 not applicable APWU01237 not applicable APWU01238 not applicable APWU01239 not applicable APWU01255 not applicable APWU01256 not applicable APWU01257 not applicable APWU01258 not applicable APWU01268 not applicable APWU01269 not applicable APWU01270 not applicable APWU01271 not applicable APWU01272 not applicable APWU01273 not applicable APWU01274 not applicable APWU01275 not applicable APWU01276 not applicable APWU01277 not applicable APWU01278 not applicable APWU01279 not applicable APWU01280 not applicable APWU01281 not applicable APWU01282 not applicable APWU01283 not applicable APWU01284 not applicable APWU01285 not applicable APWU01286 not applicable APWU01287 not applicable APWU01288 not applicable APWU01289 not applicable APWU01206 not applicable APWU01207 not applicable APWU01208 not applicable APWU01209 not applicable APWU01210 not applicable APWU01211 not applicable APWU01212 not applicable APWU01213 not applicable APWU01214 not applicable APWU01215 not applicable APWU01216 not applicable APWU01217 not applicable APWU01218 not applicable APWU01219 not applicable APWU01458 not applicable APWU01459 not applicable APWU01460 not applicable APWU00931 not applicable APWU00932 not applicable APWU00391 not applicable APWU00450 not applicable APWU00615 not applicable APWU00616 not applicable APWU00617 not applicable APWU00618 not applicable APWU00233 not applicable APWU00234 not applicable APWU00235 not applicable APWU00236 not applicable APWU00237 not applicable APWU00238 not applicable APWU01928 010084068210229221APWU0192811150917 APWU00930 not applicable APWU00939 not applicable APWU00940 not applicable APWU00941 not applicable APWU01029 not applicable APWU01030 not applicable APWU01031 not applicable APWU01032 not applicable APWU01033 not applicable APWU01034 not applicable APWU01035 not applicable APWU01036 not applicable APWU01037 not applicable APWU01038 not applicable APWU01039 not applicable APWU01040 not applicable APWU01041 not applicable APWU01042 not applicable APWU01043 not applicable APWU01044 not applicable APWU01045 not applicable APWU01046 not applicable APWU01047 not applicable APWU01048 not applicable APWU01049 not applicable APWU01050 not applicable APWU01051 not applicable APWU00679 not applicable APWU00680 not applicable APWU00681 not applicable APWU00682 not applicable APWU00683 not applicable APWU00684 not applicable APWU00685 not applicable APWU00686 not applicable APWU00687 not applicable APWU00688 not applicable APWU00689 not applicable APWU00690 not applicable APWU00691 not applicable APWU00692 not applicable APWU00693 not applicable APWU00694 not applicable APWU00695 not applicable APWU00696 not applicable APWU00697 not applicable APWU00698 not applicable APWU00699 not applicable APWU00700 not applicable APWU00701 not applicable APWU00702 not applicable APWU00703 not applicable APWU00704 not applicable APWU00705 not applicable APWU01661 not applicable APWU01662 not applicable APWU01663 not applicable APWU01664 not applicable APWU00199 not applicable APWU00200 not applicable APWU00201 not applicable APWU00202 not applicable APWU00203 not applicable APWU00204 not applicable APWU00205 not applicable APWU00206 not applicable APWU00207 not applicable APWU00421 not applicable APWU00422 not applicable APWU00423 not applicable APWU00424 not applicable APWU00425 not applicable APWU00426 not applicable APWU00427 not applicable APWU00428 not applicable APWU00429 not applicable APWU00430 not applicable APWU00431 not applicable APWU00432 not applicable APWU00433 not applicable APWU00434 not applicable APWU00435 not applicable APWU00436 not applicable APWU00437 not applicable APWU00438 not applicable APWU00439 not applicable APWU00440 not applicable APWU00441 not applicable APWU00442 not applicable APWU00443 not applicable APWU00444 not applicable APWU00445 not applicable APWU00446 not applicable APWU00447 not applicable APWU00367 not applicable APWU00368 not applicable APWU00369 not applicable APWU01461 not applicable APWU01462 not applicable APWU01463 not applicable APWU01512 not applicable APWU00209 not applicable APWU00374 not applicable APWU00375 not applicable APWU00376 not applicable APWU00377 not applicable APWU00378 not applicable APWU00908 not applicable APWU00909 not applicable APWU00910 not applicable APWU00911 not applicable APWU00405 not applicable APWU00406 not applicable APWU00407 not applicable APWU00408 not applicable APWU02037 010084068210229221APWU0203711150929 APWU02038 010084068210229221APWU0203811150929 APWU02331 010084068210229221APWU0233111151103 APWU01740 not applicable APWU00838 not applicable APWU00546 not applicable APWU00549 not applicable APWU00550 not applicable APWU00790 not applicable APWU00518 not applicable APWU00521 not applicable APWU00522 not applicable APWU00523 not applicable APWU00359 not applicable APWU00399 not applicable APWU01406 not applicable APWU01946 010084068210229221APWU0194611150918 APWU00706 not applicable APWU01833 010084068210229221APWU0183311150819 APWU00890 not applicable APWU01846 010084068210229221APWU0184611150831 APWU01847 010084068210229221APWU0184711150831 APWU01848 010084068210229221APWU0184811150831 APWU01849 010084068210229221APWU0184911150831 APWU00327 not applicable APWU00328 not applicable APWU00329 not applicable APWU00330 not applicable APWU00331 not applicable APWU00332 not applicable APWU00333 not applicable APWU00334 not applicable APWU00335 not applicable APWU00336 not applicable APWU00337 not applicable APWU00338 not applicable APWU00339 not applicable APWU00340 not applicable APWU00341 not applicable APWU00342 not applicable APWU01656 not applicable APWU01657 not applicable APWU01658 not applicable APWU01659 not applicable APWU00392 not applicable APWU00393 not applicable APWU00394 not applicable APWU00395 not applicable APWU00396 not applicable APWU00419 not applicable APWU00420 not applicable APWU00451 not applicable APWU00452 not applicable APWU00459 not applicable APWU00460 not applicable APWU00462 not applicable APWU00463 not applicable APWU00314 not applicable APWU02036 010084068210229221APWU0203611150929 APWU00792 not applicable APWU00793 not applicable APWU00461 not applicable APWU00851 not applicable APWU00852 not applicable APWU00853 not applicable APWU00854 not applicable APWU00855 not applicable APWU00856 not applicable APWU00857 not applicable APWU00858 not applicable APWU00859 not applicable APWU00860 not applicable APWU00861 not applicable APWU00862 not applicable APWU00863 not applicable APWU00239 not applicable APWU00453 not applicable APWU02154 010084068210229221APWU0215411151014 APWU02155 010084068210229221APWU0215511151014 APWU02156 010084068210229221APWU0215611151014 APWU00175 not applicable APWU02353 010084068210229221APWU0235311151112 APWU02354 010084068210229221APWU0235411151112 APWU02355 010084068210229221APWU0235511151112 APWU02356 010084068210229221APWU0235611151112 APWU02357 010084068210229221APWU0235711151112 APWU02358 010084068210229221APWU0235811151112 APWU02359 010084068210229221APWU0235911151112 APWU02360 010084068210229221APWU0236011151112 APWU02361 010084068210229221APWU0236111151112 APWU01513 not applicable APWU01514 not applicable APWU00249 not applicable APWU00379 not applicable APWU00380 not applicable APWU00381 not applicable APWU00382 not applicable APWU00383 not applicable APWU00384 not applicable APWU00385 not applicable APWU00386 not applicable APWU00387 not applicable APWU00388 not applicable APWU00389 not applicable APWU00390 not applicable APWU00798 not applicable APWU00837 not applicable APWU00220 not applicable APWU00221 not applicable APWU00547 not applicable APWU00548 not applicable APWU02255 010084068210229221APWU0225511151029 APWU02256 010084068210229221APWU0225611151029 APWU02257 010084068210229221APWU0225711151029 APWU02258 010084068210229221APWU0225811151029 APWU02259 010084068210229221APWU0225911151029 APWU02260 010084068210229221APWU0226011151029 APWU02261 010084068210229221APWU0226111151029 APWU02262 010084068210229221APWU0226211151029 APWU02263 010084068210229221APWU0226311151029 APWU02264 010084068210229221APWU0226411151029 APWU02265 010084068210229221APWU0226511151029 APWU02266 010084068210229221APWU0226611151029 APWU02267 010084068210229221APWU0226711151029 APWU02268 010084068210229221APWU0226811151029 APWU02269 010084068210229221APWU0226911151029 APWU02270 010084068210229221APWU0227011151029 APWU02271 010084068210229221APWU0227111151103 APWU02272 010084068210229221APWU0227211151103 APWU02273 010084068210229221APWU0227311151103 APWU02274 010084068210229221APWU0227411151103 APWU02275 010084068210229221APWU0227511151103 APWU02276 010084068210229221APWU0227611151103 APWU02277 010084068210229221APWU0227711151103 APWU02278 010084068210229221APWU0227811151103 APWU00228 not applicable APWU00229 not applicable APWU00230 not applicable APWU00231 not applicable APWU00232 not applicable APWU00831 not applicable APWU00832 not applicable APWU02335 010084068210229221APWU0233511151103 APWU02336 010084068210229221APWU0233611151103 APWU02337 010084068210229221APWU0233711151103 APWU02338 010084068210229221APWU0233811151103 APWU02339 010084068210229221APWU0233911151103 APWU02340 010084068210229221APWU0234011151103 APWU02341 010084068210229221APWU0234111151112 APWU02342 010084068210229221APWU0234211151112 APWU02343 010084068210229221APWU0234311151112 APWU02344 010084068210229221APWU0234411151112 APWU00354 not applicable APWU00355 not applicable APWU00356 not applicable APWU00357 not applicable APWU00358 not applicable APWU00295 not applicable APWU00298 not applicable APWU00299 not applicable APWU00300 not applicable APWU00301 not applicable APWU00360 not applicable APWU01293 not applicable APWU01294 not applicable APWU01295 not applicable APWU00830 not applicable APWU00215 not applicable APWU00216 not applicable APWU00217 not applicable APWU00218 not applicable APWU00219 not applicable APWU01809 010084068210229221APWU0180911150819 APWU01810 010084068210229221APWU0181011150819 APWU01811 010084068210229221APWU0181111150819 APWU01812 010084068210229221APWU0181211150819 APWU01813 010084068210229221APWU0181311150819 APWU01650 not applicable APWU01651 not applicable
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, to the states of AZ, CA, DC, FL, GA, ID, IL IN, KY, MD, MI, MN, MO, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI; and, to the countries of AUSTRALIA, BELGIUM. BOLIVIA, CANADA, CHILE, DENMARK, FINLAND, FRANCE, GERMANY, HUNGARIA, INDIA, IRELAND, JAPAN, KAZAKHSTAN, KOREA, KUWAIT, NETHERLANDS, NEW ZEALAND, SAUDI ARABIA, SPAIN, SWITZERLAND, THAILAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Descripción del producto
    GE Healthcare, Aisys and Aisys CS2. || Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (neonatal, pediatric, and adult).
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

GE Medical Systems, LLC
  • Dirección del fabricante
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA