Device Recall Signa HDe 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare, LLC 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    57084
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1427-2011
  • 사례 시작날짜
    2010-11-09
  • 사례 출판 날짜
    2011-02-24
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-07-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    System, nuclear magnetic resonance imaging - Product Code LNH
  • 원인
    Ge healthcare has become aware of a potential issue associated with the gradient cables being inadvertently swapped while servicing the gradients on some ge healthcare mr systems that may impact patient safety. if the gradient cables are inadvertently swapped while servicing the gradients, and the service engineer does not perform the geometry check as required in the service procedure, images m.
  • 조치
    On November 9, 2010, the firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter dated November 5, 2010 to all Consignees/Customers. The letter described the product, problem and action to be taken by the firm. GE instructed the customers to contact their local GEHC support Engineer, if they have any questions about the image orientation, or the procedures for geometry checks on thier system. Additionally, a GE Healthcare representative will install a device, which will reduce the potiential for the gradient cables to be swapped. Contact your local GEHC Support Engineer if you have any questions concerning this notification or phone: 262-548-2731.

Device

  • 모델명 / 제조번호(시리얼번호)
    SERIAL  00000006175YR4 00000006195YR2 00000008700YR7 00000008722YR1 00000008724YR7 00000010581YR7 00000011496YR7 00000011668YR1 00000012101YR2 00000012145YR9 00000012146YR7 00000012149YR1 00000012792YR8 00000013308YR2 00000011532YR9 00000005068YR2 00000006514YR4 00000006515YR1 00000006516YR9 00000006519YR3 00000006522YR7 00000006525YR0 00000006528YR4 00000006532YR6 00000006535YR9 00000006538YR3 00000006544YR1 00000012221YR8 00000005079YR9 00000005080YR7 00000005081YR5 00000005648YR1 00000005656YR4 00000005659YR8 00000005664YR8 00000006155YR6 00000006157YR2 00000006172YR1 00000006176YR2 00000006177YR0 00000006188YR7 00000006194YR5 00000006198YR6 00000006200YR0 00000006204YR2 00000007947YR5 00000007954YR1 00000007969YR9 00000007970YR7 00000007971YR5 00000008692YR6 00000008697YR5 00000008698YR3 00000008699YR1 00000008701YR5 00000008703YR1 00000008709YR8 00000008715YR5 00000008716YR3 00000008720YR5 00000008726YR2 00000008727YR0 00000008728YR8 00000008729YR6 00000008732YR0 00000008734YR6 00000009833YR5 00000010024YR8 00000010025YR5 00000010114YR7 00000010578YR3 00000010583YR3 00000010686YR4 00000010794YR6 00000010795YR3 00000010830YR8 00000010831YR6 00000010834YR0 00000010856YR3 00000010863YR9 00000011210YR2 00000011428YR0 00000011429YR8 00000011495YR9 00000011499YR1 00000011637YR6 00000011648YR3 00000011650YR9 00000011669YR9 00000011686YR3 00000011826YR5 00000011829YR9 00000011830YR7 00000011842YR2 00000012085YR7 00000012098YR0 00000012099YR8 00000012100YR4 00000012102YR0 00000012142YR6 00000012172YR3 00000012206YR9 00000012207YR7 00000012227YR5 00000012286YR1 00000012287YR9 00000012289YR5 00000012330YR7 00000012393YR5 00000012434YR7 00000012435YR4 00000012503YR9 00000012507YR0 00000012576YR5 00000012651YR6 00000012652YR4 00000012727YR4 00000012728YR2 00000012755YR5 00000012756YR3 00000012818YR1 00000012820YR7 00000012940YR3 00000012943YR7 00000012988YR2 00000012992YR4 00000012994YR0 00000012995YR7 00000013056YR7 00000013061YR7 00000013177YR1 00000013180YR5 00000013185YR4 00000013239YR9 00000013241YR5 00000013246YR4 00000013301YR7 00000013306YR6 00000013310YR8 00000013375YR1 00000013379YR3 00000013384YR3 00000013385YR0 00000013399YR1 00000013453YR6 00000013799YR2 00000013800YR8 00000013802YR4 00000013804YR0 00000004984YR1 00000011536YR0 00000012290YR3 00000006199YR4 00000010115YR4 00000005072YR4 00000005074YR0 00000006510YR2 00000006511YR0 00000006523YR5 00000006530YR0 00000006533YR4 00000006534YR2 00000006541YR7 00000006542YR5 00000006543YR3 00000006553YR2 00000006554YR0 00000006203YR4 00000010939YR7 00000010976YR9 00000012552YR6 00000012553YR4 00000012574YR0 00000012793YR6 00000012794YR4 00000012878YR5 00000012996YR5 00000013058YR3 00000013059YR1 00000013378YR5 00000013629YR1 00000013204YR3 00000013757YR0 00000013380YR1 00000010252YR5 00000012797YR7 00000012328YR1 00000012990YR8 00000013450YR2 00000012083YR2 00000013179YR7 00000010229YR3 00000006521YR9 00000006545YR8 00000006550YR8 00000005082YR3 00000006196YR0 00000010230YR1 00000012823YR1 00000013304YR1 00000013307YR4 00000013376YR9 00000004773YR8 00000005077YR3 00000006169YR7 00000008694YR2 00000008713YR0 00000008714YR8 00000010226YR9 00000011432YR2 00000012210YR1 00000006156YR4 00000010225YR1 00000012819YR9 00000012547YR6 00000006539YR1 00000006551YR6 00000008719YR7 00000008721YR3 00000010254YR1 00000011037YR9 00000011838YR0 00000012754YR8 00000011035YR3 00000011498YR3 00000011962YR8 00000011989YR1 00000013243YR1 00000013343YR9 00000005657YR2 00000006171YR3 00000006173YR9 00000006197YR8 00000007966YR5 00000007967YR3 00000010829YR0 00000010978YR5 00000011039YR5 00000011534YR5 00000011646YR7 00000011691YR3 00000011994YR1 00000012208YR5 00000012392YR7 00000012498YR2 00000012502YR1 00000012505YR4 00000012724YR1 00000013302YR5 00000013447YR8 00000013694YR5 00000013704YR2 00000013803YR2 00000006552YR4 00000012205YR1 00000012824YR9 00000012938YR7 00000013801YR6 00000013381YR9 00000012573YR2 00000013645YR7 00000010977YR7 00000011538YR6 00000012226YR7 00000012577YR3 00000012658YR1 00000013094YR8 00000013203YR5 00000011767YR1 00000013095YR5 00000012795YR1 00000012817YR3 00000013184YR7 00000013386YR8 00000013396YR7 00000013449YR4 00000013624YR2 00000011286YR2 00000011986YR7 00000006189YR5 00000011765YR5 00000012292YR9 00000013583YR0 00000005065YR8 00000005067YR4 00000005069YR0 00000006505YR2 00000006506YR0 00000006508YR6 00000006513YR6 00000006517YR7 00000006518YR5 00000006524YR3 00000006526YR8 00000006529YR2 00000006531YR8 00000006537YR5 00000006540YR9 00000006546YR6 00000006548YR2 00000005076YR5 00000005084YR9 00000005645YR7 00000005650YR7 00000005652YR3 00000005653YR1 00000005654YR9 00000005658YR0 00000005660YR6 00000005662YR2 00000006158YR0 00000006159YR8 00000006160YR6 00000006162YR2 00000006163YR0 00000006165YR5 00000006166YR3 00000006168YR9 00000006178YR8 00000006179YR6 00000006180YR4 00000006182YR0 00000006187YR9 00000006192YR9 00000006193YR7 00000006201YR8 00000007945YR9 00000007946YR7 00000007948YR3 00000007949YR1 00000007950YR9 00000007953YR3 00000007955YR8 00000007956YR6 00000007957YR4 00000007958YR2 00000007959YR0 00000007960YR8 00000007961YR6 00000007962YR4 00000007963YR2 00000007965YR7 00000007972YR3 00000007973YR1 00000007974YR9 00000008685YR0 00000008686YR8 00000008687YR6 00000008691YR8 00000008696YR7 00000008718YR9 00000008723YR9 00000008725YR4 00000009949YR9 00000009956YR4 00000010021YR4 00000010251YR7 00000010580YR9 00000010684YR9 00000010687YR2 00000010858YR9 00000010859YR7 00000010861YR3 00000011040YR3 00000011041YR1 00000011289YR6 00000011344YR9 00000011345YR6 00000011346YR4 00000011348YR0 00000011430YR6 00000011672YR3 00000011694YR7 00000011695YR4 00000011764YR8 00000011841YR4 00000011843YR0 00000011988YR3 00000011990YR9 00000011993YR3 00000012082YR4 00000012084YR0 00000012143YR4 00000012148YR3 00000012170YR7 00000012324YR0 00000012325YR7 00000012326YR5 00000012331YR5 00000012653YR2 00000012657YR3 00000012726YR6 00000012730YR8 00000012822YR3 00000012939YR5 00000012941YR1 00000013093YR0 00000013178YR9 00000013182YR1 00000013186YR2 00000013250YR6 00000013251YR4 00000012804YR1 00000013027YR8 00000013028YR6 00000013205YR0 00000013287YR8 00000013344YR7 00000013345YR4 00000013387YR6 00000013644YR0 00000004672YR2 00000005073YR2 00000006512YR8 00000006520YR1 00000006549YR0 00000012293YR7 00000006190YR3 00000010864YR7 00000011839YR8 00000011965YR1 00000012168YR1 00000012436YR2 00000012496YR6 00000013395YR9 00000013398YR3 00000013382YR7 00000013623YR4 00000013627YR5 00000013628YR3 00000013703YR4 00000011766YR3 00000013130YR0 00000011038YR7 00000012654YR0 00000010832YR4 00000011285YR4 00000011651YR7 00000011671YR5 00000011966YR9 00000012086YR5 00000012169YR9 00000012288YR7 00000012327YR3 00000012329YR9 00000012506YR2 00000012655YR7 00000012989YR0 00000013060YR9 00000013242YR3 00000013247YR2 00000013248YR0 00000013698YR6 00000013807YR3 00000011042YR9 00000010582YR5 00000006161YR4 00000006167YR1 00000012291YR1 00000013311YR6 00000012501YR3 00000012549YR2 00000006536YR7 00000008693YR4 00000009955YR6 00000010756YR5 00000010828YR2 00000011288YR8 00000011347YR2 00000011497YR5 00000011636YR8 00000011768YR9 00000011825YR7 00000012821YR5 00000013134YR2 00000013181YR3 00000006527YR6 00000005078YR1 00000005655YR6 00000008690YR0 00000009954YR9 00000006170YR5 00000006202YR6 00000008717YR1 00000013625YR9 00000006509YR4 00000006164YR8 00000012759YR7 00000009947YR3 00000013183YR9 00000012578YR1 00000013806YR5 00000006181YR2 00000006183YR8 00000006184YR6 00000006185YR3 00000006186YR1 00000007951YR7 00000007952YR5 00000008688YR4 00000008689YR2 00000008705YR6 00000008706YR4 00000008707YR2 00000008708YR0 00000008710YR6 00000008711YR4 00000008712YR2 00000008730YR4 00000008731YR2 00000008733YR8 00000009832YR7 00000010227YR7 00000010231YR9 00000010250YR9 00000010253YR3 00000010579YR1 00000010754YR0 00000010755YR7 00000010857YR1 00000010860YR5 00000010862YR1 00000011186YR4 00000011211YR0 00000011212YR8 00000011238YR3 00000011290YR4 00000011343YR1 00000011349YR8 00000011537YR8 00000011539YR4 00000011638YR4 00000011639YR2 00000011649YR1 00000011652YR5 00000011653YR3 00000011685YR5 00000011689YR7 00000011690YR5 00000011828YR1 00000011840YR6 00000011961YR0 00000011963YR6 00000011964YR4 00000011987YR5 00000011991YR7 00000011992YR5 00000012103YR8 00000012117YR8 00000012118YR6 00000012119YR4 00000012141YR8 00000012147YR5 00000012171YR5 00000012366YR1 00000012368YR7 00000012389YR3 00000012390YR1 00000012391YR9 00000012449YR5 00000012551YR8 00000012579YR9 00000012580YR7 00000012581YR5 00000012582YR3 00000012723YR3 00000012729YR0 00000012875YR1 00000012876YR9 00000012879YR3 00000012880YR1 00000012936YR1 00000012937YR9 00000012993YR2 00000013055YR9 00000013092YR2 00000013135YR9 00000013238YR1 00000013240YR7 00000013244YR9 00000013245YR6 00000013249YR8 00000013303YR3 00000013309YR0 00000013377YR7 00000013397YR5 00000013445YR2 00000013446YR0 00000013448YR6 00000013452YR8 00000013576YR4 00000013577YR2 00000013578YR0 00000013579YR8 00000013580YR6 00000013617YR6 00000013618YR4 00000013619YR2 00000013620YR0 00000013622YR6 00000013695YR2 00000013696YR0 00000013697YR8 00000013699YR4 00000013700YR0 00000013701YR8 00000013347YR0 00000013582YR2 00000013585YR5 00000013810YR7 00000011824YR0 00000013057YR5 00000007964YR0 00000008704YR9 00000009948YR1 00000010023YR0 00000010685YR6 00000010833YR2 00000011827YR3 00000012796YR9 00000011692YR1 00000012367YR9 00000012508YR8 00000012550YR0 00000012722YR5 00000012942YR9 00000013305YR8 00000013451YR0 00000013626YR7 00000013805YR7 00000006547YR4 00000006507YR8 00000006174YR7 00000010827YR4 00000011960YR2 00000012144YR2 00000012497YR4 00000012575YR7 00000012753YR0 00000012991YR6 00000013693YR7 00000012209YR3 00000011535YR2
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including DC and PR; and countries including: VIET NAM, VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TURKEY, TUNISIA, FORMER YUGOSLAV REPUBLIC OF MACEDONIA, THAILAND, TAIWAN, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, REUNION, REPUBLIC OF KOREA, PORTUGAL POLAND, PHILIPPINES, PERU,PARAGUAY, PANAMA, PAKISTAN, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MEXICO, MAURITIUS, MARTINIQUE,MALTA, MALAYSIA, LUXEMBOURG,LITHUANIA, LIBYAN ARAB JAMAHIRIYA, LEBANON, LATVIA, KUWAIT, KENYA, KAZAKHSTAN, JORDAN, JAPAN, JAMAICA, ITALY, ISRAEL, ISLAMIC REPUBLIC OF IRAN, IRELAND, INDONESIA, INDIA, ICELAND, HUNGARY, HONG KONG, HONDURAS, GUYANA, GUATEMALA, GUADELOUPE, GREECE, GERMANY, GEORGIA, FRENCH POLYNESIA, FRANCE, FINLAND, EL SALVADOR, EGYPT, ECUADOR, DOMINICAN REPUBLIC, DENMARK, CECH REPUBLIC, CYPRUS, CROATIA, COLOMBIA, CHINA, CHILE, CANDA, BULGARIA, BRAZIL, BOSNIA AND HERZEGOVINA, BOLIVIA, BELGIUM, BELARUS, AZERBAIJAN, AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA.
  • 제품 설명
    4) Signa HDe (K052978 GE 1.5T Signa HDe MR System) || The GE Signa¿ HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa¿ HDe system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
  • Manufacturer

Manufacturer

  • 제조사 주소
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
  • Source
    USFDA