FDA · Medical device recall

GE Datex-Ohmeda ADU Carestation Intended to provide general… and 2 more products

July 30, 2009

Date posted by the FDA: July 30, 2009
Status: Terminated
Filed by: GE Healthcare
Reason: GE Healthcare has received reports of breathing circuit or tubing misconnections of the Anesthesia Delivery Unit (ADU), that may impact patient safety.
Distribution pattern: USA including states of AL, AK, AZ, AR, CA, CO, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, and WI and countries of Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Bosnia & Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, England, Estonia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Iraq, Ireland, Isle of Man (UK), Israel, Italy, Japan, Jordan, Kazahkstan, Kuwait, Latin America, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Paraguay, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Yemen.

3 products in this recall

GE Datex-Ohmeda ADU Carestation Intended to provide general inhalation anesthesia and ventilatory support to…

Product: GE Datex-Ohmeda ADU Carestation Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients.
Quantity: 925
Codes and lots: 40010266 40007614 40162385 40102538 40102539 40102540 40103216 40094168 40094169 40177773 40177774 40010303 40016231 40111765 40111766 40059761 40041764 400497962 40016293 40078704 40078752 40117250 40094153 40094154 40094156 40094158 40094160 40094162 40132088 40122596 40122597 40122598 40122630 40163531 40167362 40300005 40163526 40163527 40163528 40163529 40022236 40022261 40022271 40022274 40075058 40075059 40075064 40075091 40124797 40221729 40221730 40221731 40221732 40221733 40221734 40221735 40143446 40143449 40143450 40145288 40145289 40145290 6035764 40113769 40013565 40015856 40150842 40016222 40016223 40117249 40170266 40178071 40049737 40001801 40003091 40003092 40059753 40059754 40059756 40059757 40059758 40224004 40224005 40080038 40110693 40110694 40110695 40110696 40110697 40110698 40110699 40102544 6017408 6017409 6017410 6048828 6048838 6048839 6048840 6048848 6050870 6067632 6067633 6067635 6067643 6067644 6085929 6125598 6125599 6125600 6125600 6125600 6125613 6125632 6190628 6190630 6190631 6190632 6190634 6190635 6190636 6190637 6190686 6190687 6190688 6215605 6228766 6228775 6228776 6233461 6253230 6262556 6333586 6333587 6355795 6369322 6370000 6395498 6395500 6399282 6399283 6399284 6399285 6399286 6400975 6400976 6400977 6400978 6400979 6400980 6400981 6400982 6400983 6400984 6408476 6408477 6408480 6408481 6410761 6410762 6410763 6410764 6410765 6410766 6410769 6410772 6410773 6414818 6414819 6414820 6414821 6419339 6419340 6424402 6433523 6253231 6253233 6253234 6253235 6257636 6257637 6353699 6410770 6410771 40177769 40177770 40177771 40177772 40045381 40030638 40030644 40070254 40070257 40070258 40070288 40141306 40045436 40045437 40080044 40080059 40016291 40019506 40114918 40114920 40114436 40114435 40005769 40007649 40007651 40045371 40102550 40102551 40102552 40102553 40102554 40102555 40300721 40300722 40070255 40122619 40143403 40155734 40155735 40162386 40007657 40114437 40114438 40114898 40114899 40114900 40114901 40114902 40114903 40080043 40080061 40061980 40061981 40061982 40061983 40032200 40043542 40049736 40070295 40080047 40080048 40163535 40163536 40163537 40163538 40163539 40209833 40209837 40122617 40002864 40003083 40003084 40003481 40003484 40019600 40020767 40016228 40032305 40032306 40078718 40080084 40143410 40209824 40132118 40132119 40132120 40070293 40070294 40070296 40092319 40092320 40177846 40177848 40030684 40030685 40030686 40030687 40030690 40030691 40030693 40078699 40122637 40049753 40061986 40045314 40045315 40113765 40113766 40051763 40030744 40022269 40022272 40045378 40045380 40045382 40070329 40113736 40111767 40111768 40111769 40111772 40111773 40111774 40300718 40070330 40092355 40092356 40129920 40110701 40111761 40111762 40111763 40111764 40095140 40095141 40095142 40095143 40095144 40013608 40013613 40013628 40013631 40013638 40049807 40070256 40145316 40071128 40157487 40030743 40032353 40032354 40032355 40043463 40043465 40045374 40070286 40070287 40111800 40118127…
Recall started: Oct. 30, 2008
Device type: Gas-Machine, Anesthesia
Root cause (FDA): Other
What the company told customers: A GE Healthcare "Urgent Medical Device Correction" letter was sent to consignees on 1/16/09. The letter was addressed to Health Care Administrator, Chief of Anesthesia and Director of Clinical Engineering. The letter described the Safety Issue; Affected Product Details; Safety Instructions, which include clinical personnel being properly trained on the correct connections of breathing circuit tubing and proper execution of System Checkout according to the ADU URMs; Product Correction and Contact Information.
Recall number: Z-1633-2009

Datex-Ohmeda AS/3 Anesthesia Delivery Unit An Anesthesia Gas Machine for composition of anesthetic breathing…

Product: Datex-Ohmeda AS/3 Anesthesia Delivery Unit An Anesthesia Gas Machine for composition of anesthetic breathing gas and manual or mechanical ventilation for patients undergoing anesthesia. Indicated for all persons that require inhalation anesthesia.
Quantity: 2,087
Codes and lots: 40075019 40075024 40075020 40075017 40075013 40075022 40075039 40075015 40065386 40065387 40065377 40065371 40065362 40065359 40065363 40065364 40065360 40065361 40061972 40061977 40061979 40061978 40061971 40061976 40061970 40061969 40051823 40056998 40056922 40056994 40054534 40056993 40056996 40056997 40056999 40051794 40051824 40056995 40054501 40049789 40049791 40054502 40054499 40054500 40054498 40051802 40054497 40054496 40054494 40054495 40054493 40051732 40051747 40051736 40051745 40051735 40051758 40051746 40051755 40051759 40051754 40051717 40051725 40051715 40049821 40049834 40049817 40049818 40049814 40049825 40049824 40049820 40049831 40049811 40049816 40049826 40049819 40049813 40049815 40049812 40049810 40049806 40049784 40049785 40049772 40049786 40049773 40049770 40049743 40049741 40049742 40049739 40049740 40049734 40049732 40049733 40049767 40049747 40049749 40049748 40049697 40049707 40049705 40049706 40049696 40049714 40049711 40049704 40049698 40049713 40049712 40049700 40049708 40049715 40049710 40049688 40049687 40049685 40049686 40045442 40045445 40045439 40045438 40045441 40045440 40045392 40045402 40045375 40045401 40045368 40045385 40045390 40045386 40045384 40045387 40045389 40045395 40045341 40045350 40045349 40045343 40045345 40045319 40045344 40045340 40043540 40043541 40043495 40043498 40043483 40043501 40043502 40043500 40043474 40043481 40043493 40043494 40043499 40043496 40043497 40043482 40043473 40043477 40043479 40043476 40043480 40043478 40043475 40032546 40032596 40032580 40032287 40032343 40032332 40032321 40032318 40032335 40032334 40032327 40033028 40032330 40032340 40032345 40032347 40032338 40032339 40032311 40032307 40032300 40032308 40032233 40032231 40032218 40032179 40032194 40032190 40032195 40032196 40032192 40032197 40032216 40032219 40032235 40032217 40032185 40032172 40032198 40032189 40032199 40032176 40032175 40032182 40032178 40032186 40032170 40032188 40032187 40028025 40027777 40027779 40027778 40027776 40027782 40027783 40027775 40027717 40027697 40027685 40027688 40027718 40027693 40027698 40027716 40027691 40027681 40027686 40022374 40027683 40027682 40027679 40022368 40022364 40010338 40010315 40019521 40019530 40030767 40049769 40030564 40030565 40030566 40030568 40032516 40045369 40045370 40049809 40059763 40059764 40065392 40016277 40016266 40016271 40016265 40016241 40016243 40030677 40045452 40003082 40001779 40007641 40007639 40016298 40019503 40019540 40019544 40030765 40030764 40059732 40059730 40059731 40059723 40059728 40059735 40059729 40059733 40059734 40057010 40057011 40057004 40057008 40057007 40057009 40057006 40057005 40057003 40057001 40057012 40057002 40004947 40007673 40007683 40004953 40004950 40007648 40007712 40007706 40010269 40010268 40010276 40007627 40010277 40010280 40010271 40010265 40007619 40010299 40010278 40007628 40010353 40010348 40010351 40010349 40010312 40010270 40010350 40010363 40013574 40010343 40013584 40013585 40010360 40013575 40010352…
Recall started: Oct. 30, 2008
Device type: Gas-Machine, Anesthesia
Root cause (FDA): Other
What the company told customers: A GE Healthcare "Urgent Medical Device Correction" letter was sent to consignees on 1/16/09. The letter was addressed to Health Care Administrator, Chief of Anesthesia and Director of Clinical Engineering. The letter described the Safety Issue; Affected Product Details; Safety Instructions, which include clinical personnel being properly trained on the correct connections of breathing circuit tubing and proper execution of System Checkout according to the ADU URMs; Product Correction and Contact Information.
Recall number: Z-1634-2009

Datex-Ohmeda S/5 Anesthesia Delivery Unit Intended to provide general inhalation anaesthesia and ventilatory…

Product: Datex-Ohmeda S/5 Anesthesia Delivery Unit Intended to provide general inhalation anaesthesia and ventilatory support to a wide range of patients. Intended for volume or pressure control, pressure support and synchronized intermittent mandatory (SIMV) ventilation modes.
Quantity: 6,621
Codes and lots: 6505591 6504143 6504144 6505588 6488527 6482851 6478332 6478333 6478334 6482385 6478325 6474359 6472276 6472278 6472279 6474357 6472280 6465283 6465282 6472271 6453235 6453236 6438719 6438718 6438723 6438723 6424397 6438712 6438712 6433525 6433526 6433527 6424397 6423152 6424394 6423156 6423157 6423158 6424393 6423153 6423154 6419336 6419337 6419338 6414823 6403878 6403880 6403883 6408473 6408474 6408113 6403881 6399280 6399281 6395497 6393520 6395487 6395489 6393514 6393515 6382828 6382829 6382830 6382831 6382833 6390074 6390075 6390436 6390437 6390438 6391069 6391070 6391071 6391072 6391073 6391074 6380586 6380587 6380582 6374511 6374512 6374513 6370003 6369999 6368798 6368052 6368053 6365585 6367921 6363659 6363651 6355792 6355793 6355794 6351433 6351434 6351435 6351436 6351438 6351439 6353705 6353706 6353707 6353709 6355786 6355787 6353701 6353702 6353703 6351440 6351441 6351442 6353695 6353704 6353708 6358409 6358408 6358407 6358406 6358405 6353697 6353696 6351437 6241024 6241028 6241032 6246176 6222219* 6241030 6241027 6236404 6241026 6215604** 6215609** 6215607** 6241021 6246177 6241031 6241039 6241029 6236405 6241020 6236407 6215621 6215607 6215609 6215604 6190700 6190701 6190702 6190704 6125604 6125605 6190692 6190693 6190694 6190695 6190698 6190699 6125601 6190676 6125603 6125606 6125607 6182956 6190619 6190621 6182958 6182944 6182945 6182946 6125595 6125596 6125516* 6125519* 6125590 6125591 6125592 6125593 6125594 6125584 6125587 6125576 6125579 6125580 6125577 6125546 6125548 6125527 6125526 6125516 6125519 6125504 6125505 6125506 6125507 6125508 6125509 6125510 6125511 6125502 6125627 6125499 6125500 6125628 6125629 6125630 6125471 6125472 6125473 6125474 6125475 6125476 6125483 6125484 6125485 6125486 6125497 6125498 6125631 6125459 6125443 6097443 6097444 6097445 6097452 6097455 6097457 6097458 6097463 6097464 6097465 6097466 6097467 6097468 6097469 6097470 6097474 6097476 6097481 6097454 6097387 6067703 6085924 6097375 6097376 6097377 6097378 6097379 6097380 6097381 6097382 6097383 6097384 6097426 6097427 6097428 6097429 6097430 6097431 6097432 6097433 6097434 6097435 6097436 6097437 6097438 6097439 6097440 6097441 6097442 6097409 6097410 6097411 6097412 6097413 6097414 6097415 6097416 6097417 6097418 6097419 6097420 6097421 6097422 6097423 6097424 6097425 6097393 6097401 6097403 6097404 6097405 6097406 6097407 6097408 6097504 6097394 6097395 6097391 6097392 6085915 6085916 6085918 6085925 6086605 6097358 6097360 6097362 6097363 6097371 6097365 6097366 6097368 6097369 6097370 6086599 6086607 6086590 6086604 6086592 6067669 6067671 6067679 6067708 6067670 6067693 6067641 6067680 6067681 6067682 6067715 6067648 6067649 6067656 6067660 6067678 6067723 6067662 6067710 6067645 6067646 6067647 6067642 6067655 6067658 6067639 6067640 6067650 6067719 6067722 6067638 6067634 6067636 6067627 6067628 6067726 6048809 6048836 6048837 6067724 6048824 6048825 6048826 6048811 6048813 6048817 6048818 6048820 6048821 6048822 6048841 6048842…
Recall started: Oct. 30, 2008
Device type: Gas-Machine, Anesthesia
Root cause (FDA): Other
What the company told customers: A GE Healthcare "Urgent Medical Device Correction" letter was sent to consignees on 1/16/09. The letter was addressed to Health Care Administrator, Chief of Anesthesia and Director of Clinical Engineering. The letter described the Safety Issue; Affected Product Details; Safety Instructions, which include clinical personnel being properly trained on the correct connections of breathing circuit tubing and proper execution of System Checkout according to the ADU URMs; Product Correction and Contact Information.
Recall number: Z-1635-2009

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

Source: FDA · Medical device enforcement reports, recall numbers Z-1633-2009, Z-1634-2009, Z-1635-2009. The agency record governs; check it and the company before acting.

Report a mistake on this page