Events

Recall of GE DatexOhmeda ADU Carestation

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    50800
  • Event Risk Class
    Class 2
  • Event Number
    Z-1633-2009
  • Event Initiated Date
    2008-10-30
  • Event Date Posted
    2009-07-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77325
  • Notes / Alerts
    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.
  • Extra notes in the data
    Gas-Machine for Anesthesia - Product Code BSZ
  • Reason
    Ge healthcare has received reports of breathing circuit or tubing misconnections of the anesthesia delivery unit (adu), that may impact patient safety.
  • Action
    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.

Device

GE DatexOhmeda ADU Carestation
  • Model / Serial
    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 40118128 40163530 40105960 40105962 40105963 40105964 40132171 40132172 40030559 40030560 40032505 40032506 40080045 40080046 40045448 40045449 40122633 40122634 40013611 40013565 40103806 40105961 40007664 40007667 40007680 40007693 40016295 40016305 40094155 40122631 40122632 40149177 40032288 40032289 40032303 40013594 40016217 40080054 40080080 40081618 40070289 40070290 40070291 40070292 40111770 40178086 40178087 40178088 40080049 40080081 40080110 40065346 40065347 40065348 40065349 40065350 40145311 40300029 40300717 40016221 40132160 40136605 40136608 6382827 6418319 40010273 40016194 40022351 40027695 40078721 40084516 40105923 40132109 40132110 40132111 40132112 40132113 40132161 40132168 40132182 40132191 40136591 40136592 40136593 40136594 40136595 40136600 40136602 40136604 40136606 40136607 40136609 40136610 40136633 40136636 40136689 40136690 40136692 40136693 40139461 40139468 40139524 40139525 40139529 40139531 40139534 40139535 40139536 40139537 40139538 40139541 40139544 40139545 40139546 40139548 40139549 40139558 40139559 40139560 40139561 40139562 40139563 40139564 40139565 40139566 40141274 40141275 40141276 40141277 40141278 40141279 40141280 40141281 40141282 40141283 40141284 40141285 40141286 40141287 40141288 40141289 40142739 40143408 40143411 40143412 40143413 40143414 40143431 40154349 40154381 40155736 40170281 6365574 40045365 6067695 6067696 6067697 6067707 6085919 6086567 6086568 6086569 6086570 6086571 6086572 6086578 6086579 6086580 6086587 6097359 6097448 6097449 6097450 6097451 6125438 6125439 6125440 6125478 6125515 6125553 6125554 6125555 6125556 6125558 6125560 6125582 6125583 6125586 6190690 6190706 6190708 6190709 6215608 6215617 6215632 6222209 6222212 40049693 40075048 40091303 40092340 40092365 40117222 40139557 40157535 40157536 40157537 40157538 40157539 40157540 40157541 40157542 40157543 40157550 40157551 40157552 40157553 40157554 40157555 40160755 40160757 40160769 40160770 40160771 40160772 40160773 40160774 40160775 40160776 40160777 40160778 40160779 40160780 40160781 40160782 40160783 40160784 40160785 40160786 40160787 40160788 40160789 40160790 40160791 40160792 40160793 40160794 40160795 40160796 40160797 40160798 40160799 40160829 40160830 40160831 40162292 40164502 40164503 40167407 40167408 40167413 40167414 40167415 40170242 40170243 40170244 40170245 40170246 40170247 40170248 40170249 40170250 40170251 40170252 40170254 40170255 40170256 40170257 40170258 40170263 40170268 40170269 40170270 40170271 40170272 40170273 40170274 40170275 40170276 40170277 40170278 40170279 40170280 40170282 40170283 40170284 40170285 40170286 40170287 40170288 40170289 40170290 40170291 40170292 40170293 40170294 40177935 40177936 40177937 40178060 40178061 40178062 40178063 40178064 40178065 40202508 40202509 40202510 40209768 40209769 40209770 40209771 40209772 40209773 40209774 40209775 40209776 40209777 40209779 40209781 40209794 40209795 40209802 40209803 40209804 40209805 40209806 40214038 40214041 40214042 40214043 40214051 40214052 40214053 40214055 40214056 40223033 40224773 40224774 40224775 40224776 40224777 40224778 40224779 40224780 40224781 40224782 40224783 40224784 40224785 40224786 40224787 40225803 40225805 40225809 40225821 40300729 40300731 40300732 40300733 40300734 40300735 40300737 6341970 6355789 6355790 6358411 6367925 6393513 6410759 5125440 6236408 6241023 6246179 6280793 6280794 6285888 6285889 6307166 6312311 6333579 6333580 6333581 6333582 6358410 6393515 291103 293187 293205 293314 293315 293344 293401 293815 293822 293823 293824 293825 299302 40000565 40003087 40003089 40003099 40004949 40004956 40010272 40010281 40010304 40010310 40010356 40013587 40013647 40013648 40013649 40013657 40013665 40016192 40016196 40019511 40019517 40019572 40019578 40019579 40019581 40019584 40019593 40019608 40019610 40022162 40022188 40022208 40022223 40022246 40022247 40022250 40022251 40022254 40022355 40022367 40027690 40027692 40027694 40027696 40027720 40027721 40027722 40027723 40027724 40027730 40027731 40027732 40027733 40027766 40027768 40030503 40030504 40030505 40030506 40030507 40030511 40030525 40030527 40030528 40030529 40030530 40030533 40030534 40030538 40030539 40030540 40030541 40030542 40030642 40030643 40030645 40030646 40030647 40030664 40030666 40030672 40030676 40031325 40032169 40032369 40032514 40032541 40032547 40032548 40032553 40032554 40032556 40032557 40032558 40032559 40032560 40032561 40032562 40043467 40043468 40043469 40043470 40043471 40043472 40045358 40045361 40045362 40045363 40045385 40045399 40045405 40045426 40045427 40045428 40045429 40045430 40045431 40045432 40045433 40045434 40045435 40045450 40045451 40045454 40045455 40049689 40049690 40049691 40049692 40049694 40049695 40049719 40049720 40049721 40049722 40049723 40049725 40049726 40049727 40049728 40049729 40049730 40049731 40049750 40049751 40049752 40049754 40049755 40049757 40049762 40049763 40049764 40049765 40049766 40049823 40049863 40061949 40061950 40061951 40061952 40061953 40061954 40061955 40061956 40061957 40061958 40061959 40061960 40061961 40061964 40061965 40065366, and 6454601.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    GE Datex-Ohmeda ADU Carestation || Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • Manufacturer Address
    GE Healthcare, 9900 Innovation Drive, Wauwatosa WI 53226
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA