Device Recall GE Healthcare Optima XR220amx 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Medical Systems, 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
    72974
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0768-2016
  • 사례 시작날짜
    2015-12-23
  • 사례 출판 날짜
    2016-02-08
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-09-07
  • 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, x-ray, mobile - Product Code IZL
  • 원인
    Potential safety latch mechanism failure. the safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. a fall of the arm assembly could result in bodily harm to a person.
  • 조치
    Consignees were sent on 12/23/2015 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 10906 dated December 18, 2015. The letter was addressed to Director of Biomedical Engineering, Director of Radiology and Chief of Cardiology. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Customers may continue to use the system. The firm will correct the affected devices and no charge to the customer; and a GE Healthcare representative will contact customers to arrange for the correction. For questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot or Serial numbers including but not limited to: 00001033715WK2, 12535HL3, 00000078321HL7, 00000096815HL6, 00000081147HL1, 00001032621WK3, 00000092076HL9, 00000092382HL1, 00000460115GE9, 00000079932HL0, D3s14793, 00000088642HL4, 116635HL4, 120632HL5, GEGR2411, GEGR5073, 00001027151WK8, 00000129105HL3, 261417HP0, 261416HP2, 1035189WK8, 00000084720HL2, 00000087109HL5, 00000100735HL0, 121206HL7, 125007HL5, 125019HL0, 1028231WK7, 00000126237HL7, 00000102072HL6, 00000092394HL6, 00000115802HL1, 124167HL8, 00001033721WK0, 00000108520HL8, 00000087928HL8, 00000111794HL4, 00000110657HL4, 00000092629HL5, 119090HL9, 00000442129GE3, 00000128179HL9, 00000110710HL1, 83621HL3, 00000082207HL2, 1034762WK3, 00000081499HL6, 00000088705HL9, 00000085601HL3, 00001031247WK8, 00000084721HL0, 00000084410HL0, 00000086179HL9, 1033866WK3, 00000084286HL4, 00000096817HL2, 00000092948HL9, 00000106841HL0, 00000105475HL8, 00001033220WK3, 00000106072HL2, 00000110662HL4, 00000106055HL7, 00000008789HL5, 00000084415HL9, 00000084713HL7, 00000091763HL3, 00000093367HL1, 123730HL4, 00000109436HL6, 00000078816HL6, 00000078490HL0, 120816HL4, 00000124501HL8, 00000124510HL9, 123456789, 00000095656BT5, 118267HL4, 00000081688HL4, 00000110668HL1, 123737HL9, 00000081500HL1, 00000084711HL1, 00000085596HL5, 00000118284HL9, 00000124201HL5, 00000118285HL6, 00000118462HL1, 00000118282HL3, 00000104908HL9, 00000102090HL8, 00000100174HL2, 120182HL1, D3S141084, 00000100430HL8, 00000097754HL6, 114137HL3, 00000099201HL6, 00000099204HL0, 00000111427HL1, 00000087073HL3, 120184HL7, 00000126701HL2, 00000128172HL4, 00000124478HL9, 00000124224HL7, 00000091044HL8, 00000107457HL4, 00000076792HL1, 00000112148HL2, 00001032707WK0, 00000101689HL8, 119104HL8, 00001027765WK5, 114191HL0, 00000085591HL6, 00001030627WK2, 00001030293WK3, 00001030654WK6, 00001030617WK3, GEGR3510, 119099HL0, 00000106829HL5, 120187HL0, 00000087076HL6, 00000124186HL8, 00000098182HL9, 120829HL7, 00000093383HL8, 124217HL1, 122883HL2, 121230HL7, 112145HL8, 00001033608WK9, 00000096582HL2, 121229hl9, 00000081796HL5, 00000404458GE2, 00000076912HL5, 00000080863HL4, 00000108423HL5, 00001030034WK1, 120159HL9, 00001029071WK6, 00000093374HL7, 00000087107HL9, 00001031749WK3, 00000091761HL7, 00000086996HL6, 00000092073HL6, 00001035466WK0, 133379BT8, 00001034661WK7, GEGR2475, 00000081817HL9, 00000124181HL9, 00000111919HL7, 00000109407HL7, 00000105795HL9, 00000106056HL5, 00000116630HL5, 00001027347WK2, 00000083537HL1, 00000086155HL9, 00000078491HL8, GEGR3252, 00000089859HL3, 00000096580HL6, 15B1433, 00000077251HL7, 00001031962WK2, 00001035186WK4, 00000081496HL2, 00000088645HL7, 00000080783HL4, 120808HL1, 00000087094HL9, 00000105455HL0, 00000119756HL5, 00001035456WK1, 00000083015HL8, 00000082740HL2, 00000084147HL8, 4123, 00000085042HL0, 00000087890HL0, 00001029042WK7, 00001031728WK7, 00000076403HL5, 00000092392HL0, 00000081819HL5, 00000125677HL5, 00000149748BT6, 00000101296HL2, 00000109423HL4, 00000108571HL1, 00000109425HL9, 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00000098190HL2, 00000081813HL8, 00000083014HL1, 00000110661HL6, 00000116668HL5, 00000114168HL8, 00000117878HL9, 1035442WK1, 1035445WK4, 1035451WK2, 00001035814WK1, 146939BT4, 00000108117HL3, 00000086998HL2, 00000084421HL7, 00000098177HL9, 5331287, 00000412940GE9, 117873HL0, 00000120191HL2, 00000078489HL2, 00000079281HL2, 00000079113HL7, 120824hl8, 00000086395HL1, 129189BT7, 00000096588HL9, 112099HL7, 1029826WK3, 00000434607GE8, 00000078324HL1, 00000080634HL9, 00000081809HL6, 00001029900WK6, 00000092947HL1, 00000079628HL4, 00000077772HL2, 00000104589HL7, 00000091416HL8, 00000095354HL7, 120203HL5, 122219HL9, 00000106058HL1, 00000082248HL6, 00000092379HL7, 00000076907HL5, 00000086981HL8, 00000080775HL0, 00000084395HL3, 00001029961WK8, 00000111413HL1, 00000083022HL4, 00000083593HL4, 117201HL4, 00000084146HL0, 00000084173HL4, 124494HL6, 00000080692HL7, 00000098184HL5, 122233HL0, 120193HL8, 00000084409HL2, 00000087082HL4, 00000098978HL0, 00000085896HL9, 00000121165HL5, 00000104500HL4, 113110HL1, 00001035742WK4, 00001035737WK4, 00001035728WK3, 00000113110HL1, 00000122896HL4, 00000122904HL6, 00000118281HL5, 00000104896HL6, 00000079923HL9, 00001035544WK4, 00000008877HL9, 00000117198HL2, 00000079631HL8, 00000092615HL4, UA45275-4, 00001033247WK6, 00000098912HL9, 116647HL9, 115507HL6, 00000118699HL8, 00000110690HL5, 00000112101HL1, 00000110694HL7, 00000112097HL1, 00000080876HL6, 00001028279WK6, 00000083618HL9, 00000084106HL4, 00000084398HL7, 00000108527HL3, 00001031031WK6, 00001031063WK9, 00001030850WK0, 00001031014WK2, 00001031007WK6, 00001031009WK2, 00000091759HL1, 00000118453HL0, 00000118278HL1, 00000118460HL5, 00000118466HL2, 00000118707HL9, 00000120165HL6, 00000089149HL9, 118685HL7, 00001030901WK1, 00000098632HL3, 00000079922HL1, UA47328-8, 00000085025HL5, GEGR4113, 00000085054HL5, 00000098172HL0, 00000118454HL8, 00000119111HL3, 00000095903HL1, 118271HL6, 102800WK2, 00000101300HL2, 00000101298HL8, 00000078823HL2, 000000011H1357, 00000081492HL1, 00000077244HL2, 00000079555HL9, 00000077484HL4, 00000079925HL4, 00000087078HL2, 00000120175HL5, 00000098615HL8, 00000086706BT9, 00000079114HL5, 00000086381HL1, 00000078817HL4, 00000117184HL2, 99176HL0, 120192HL0, 00000085028HL9, 00000096811HL5, 00001028119WK4, 00001030628WK0, 114179HL5, 00000106828HL7, 00000085600HL5, 00000404497GE0, 115773HL4, 3535353, 81797HL3, 85653HL4, 00000117430HL9, 00000103790HL2, 00001036965WK0, 00000091402HL8, 00001029680WK4, 101515, 00000109391HL3, 00000103784HL5, 00000115496HL2, 00000115497HL0, GEGR3657, 00001033635WK2, 00000103625HL0, 00000101702HL9, 00000102071HL8, 00000087856HL1, 124495HL3, 00000084184HL1, 00000108524HL0, 00000079287HL9, 00000107165HL3, 116633HL9, 116626HL3, 115790HL8, 00000084718HL6, 00000087926HL2, 00000088646HL5, 00000095325HL7, 00000085646HL8, 00000086182HL3, 00000091418HL4, 1030814WK6, 00000114091HL2, 00000237329HP8, 88766HL1, 00000095900HL7, 00001036143WK4, GEGR4245, 00000098980HL6, 00000088758HL8, 00000087888HL4, 00000087933HL8, 00001029887WK5, 00001028521WK1, 00001029825WK5, 00001030594WK4, 00000099187HL7, 1028267WK1, 00000085431HL5, 00000085593HL2, 00000106078HL9, 00000083543HL9, GEGR2368, 00000086156HL7, 00000246601HP9, 00000110651HL7, 00000110644HL2, 00000077483HL6, 00000099189HL3, 00000092072HL8, 00000098209HL0, 00001031505WK9, 00000115794HL0, 00000117177HL6, 00000098214HL0, 00000099174HL5, 00000100187HL4, 108415HL1, 00000277721GE7, 00001031490WK4, 00001031222WK1, 00000084408HL4, 00000087892HL6, 00000085650HL0, 00000080869HL1, 00000083026HL5, 00001031522WK4, 00001031523WK2, 00000087106HL1, 00001033243WK5, 120180HL5, 00000085597HL3, 00000087099HL8, 00000104505HL3, 132564, 00001035414WK0, 00000107469HL9, 128724hl2, 00001033770WK7, 00001033769WK9, 00001033785WK5, 00001033810WK1, 00001033639WK4, 00001033641WK0, 00000102088HL2, 00000099156HL2, 00000086999HL0, GEGR4648, 00000415476GE1, 00000109413HL5, 00000087883HL5, 00000085048HL7, 00000079933HL8, 00000083609HL8, 00000085893HL6, 00000087925HL4, 00000091423HL4, 00000091200HL6, 00000087103HL8, 00001033542WK0, 00000076402HL7, 00000101305HL1, 00000112102HL9, xa44867-4, 00000404454GE1, 128714hl3, 00000108553HL9, 00000081490HL5, 00000081151HL3, 102090HL8, 00000440403GE4, 00000116642HL0, 119733BT4, 1035719wk2, GEGR4464, 1035718WK4, 00000106080HL5, 1035671wk5, 1035674WK9, 83615HL5, 00000079557HL5, 122221HL5, 120652HL3, 00000113109HL3, 00000077472HL9, 00000085044HL6, 120837HL0, 00000079927HL0, 00001033046WK2, 00000098207HL4, 00000100176HL7, 00000102998HL2, 00000101703HL7, 00000102085HL8, 00000089138HL2, 00000089145HL7, 00000109400HL2, 00000084109HL8, 00000101688HL0, 00001033700WK4, 00000078814HL1, 00001033325WK0, 00000078821HL6, 00001033244WK3, 00000078824HL0, 00000079554HL2, 00000102999HL0, 00000100170HL0, 00000103000HL6, 00000102074HL2, 00000102089HL0, 00000093391HL1, 00000101302HL8, 00000092066HL0, 00000087763HL9, 00001032988WK6, 00000085901HL7, 00000085059HL4, 00000091757HL5, 00000113105HL1, 00000081794HL0, 00000096576HL4, 00000099161HL2, 00000092067HL8, 00000086980HL0, 00000104584HL8, 00000101292HL1, 00000091043HL0, 00000086167HL4, 00000083613HL0, 00000084736HL8, 120660HL6, 118702HL0, 120645HL7, 118543HL8, 117204HL8, 00000078819HL0, 00000111924HL7, 122004HL5, 00000083596HL7, 00000082745HL1, 00000084723HL6, 00000097755HL3, 00000085905HL8, 00000085427HL3, 00000080854HL3, 00000104923HL8, 00000108577HL8, 84733HL5, 00000118675HL8, 00000077248HL3, 120163HL1, 00000079288HL7, 00000096816HL4, 00000101289HL7, 00000095338HL0, 00000095351HL3, 00000104941HL0, 00000119110HL5, 00000087918HL9, 00000085907HL4, 00000081695HL9, 00000078322HL5, 00000079279HL6, 00000080687HL7, 00000087886HL8, 00000106690HL1, 00000106695HL0, 00001032823WK5, 00000084110HL6, 00000081483HL0, 00000084396HL1, 00000095909HL8, 00000081811HL2, 00000106057HL3, 00000083540HL5, 00000081497HL0, 121227HL3, 00000085655HL9, 103619WK3, 117855HL7, 00000107160HL4, 00000090968HL9, 00000093399HL4, 00000095339HL8, 00000108565HL3, 00000084426HL6, 00000099173HL7, GEGR4078, 00000101079HL2, 00000115246HL1, 00000115490HL5, 00000080630HL7, 120684HL6, 00000098213HL2, 119095HL8, 00000077922HL3, 00000108535HL6, 00000108547HL1, 00000098189HL4, GEGR4570, 123456, GEGR4538, 00000078495HL9, 00000087105HL3, 00001035373WK8, 00000122215HL7, 00000087891HL8, 00000099203HL2, 00001035591WK5, 00000087111HL1, 00000122208HL2, 00000122209HL0, 00000110646HL7, 00000120170HL6, 00000128178HL1, 00000087937HL9, 00000076795HL4, GEGR180, 00000106689HL3, 1036518WK7, 118684HL0, 00000087857HL9, 00000098623HL2, 00000076794HL7, 00000104946HL9, 00000105459HL2, 00000104938HL6, 00000104947HL7, 00000105460HL0, 00000106079HL7, 00000106075HL5, 00000106835HL2, 00000106842HL8, 00000106827HL9, 00000108523HL2, 00000108518HL2, 00000076458HL9, 00000078820HL8, 00000080857HL6, 00000080779HL2, 120823HL0, 00000108519HL0, 00000108419HL3, 00000108422HL7, 00001033501WK6, 00000126695HL6, 124488HL8, 125695HL7, 00000126923HL2, 00000081158HL8, UA47199-3, 00000087861HL1, 00000081161HL2, 00001029903WK0, 00000086174HL0, 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00000120674HL7, 00000122207HL4, 121194HL5, 00000115792HL4, 00000110114HL6, 00000108567HL9, 00000101080HL0, 00000098218HL1, 120157HL3, 141971BT2, 141763BT3, 00000110108HL8, 00000091396HL2, 00001033526WK3, 1030927WK6, 1036188K9, 00000123720HL5, 00000125009HL1, 00000085057HL8, 00001033598WK2, 00001033497WK7, 00000108568HL7, 110716HL8, 00000099199HL2, 00001031707WK1, 00000102070HL0, 00001033846WK5, 00001033860WK6, 00001033848WK1, 00001033812WK7, 00001033847WK3, 00000079930HL4, 00000115772HL6, 00000115786HL6, 00000114090HL4, 00000115793HL2, 00000116628HL9, 00000115789HL0, 00000115230HL5, GEGR3672, XA44939-8, 00000451441GE0, 81164HL6, GEGR4159, 00000125694HL0, 00000126226HL0, 00000098199HL3, 00000098208HL2, 122228HL0, UA45964-6, 1035064WK3, 00000096586HL3, 124173HL6, 124171HL0, 00000124173HL6, 114186HL0, 00000117188HL3, 00000126243HL5, 00000126925HL7, 00000124477HL1, 1865992, 00001033632WK9, 00001033603WK0, 00000101974HL4, 103144204, 00000095896HL7, 00000081822HL9, 00000082741HL0, 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00001031572WK9, 00000110107HL0, GEGR4593, 00000106838HL6, 114190HL2, 115764HL3, GEGR2559, GEGR3991, 00000081820HL3, GEGR4004, 00000079109HL5, 1027505WK5, 00000079274HL7, 00000108532HL3, 00000104578HL0, 00000100171HL8, 00000100742HL6, 00000084404HL3, 00000115491HL3, 00000115494HL7, 00000122921HL0, 00000100420HL9, 00000087765HL4, 1029046wk8, 120164HL9, 00000105464HL2, 00000084911HL7, 00000085052HL9, 00000095908HL0, 00001031208WK0, 00001031178WK5, 00000103621HL9, 00000118276HL5, 00000118468HL8, 1035210WK2, 00000081689HL2, 00000089141HL6, 00000089150HL7, 117202HL2, 00000084401HL9, 00000085051HL1, 00000087855HL3, 00000100737HL6, 000000GEGR2552, 00000118556HL0, 1033944WK8, 1034140WK2, 118682HL4, 00000105802HL3, 00000105463HL4, 00000122261HL1, 00000106049HL0, 00000127658HL3, 00000104944HL4, 00000112105HL2, 00000100183HL3, 00000079920HL5, 00000079926HL2, 00000118465HL4, 00000088643HL2, 00000117877HL1, 00000118272HL4, 00000082476HL3, 00000115486HL3, 00000087068HL3, 00000091752HL6, 00000117859HL9, 00000116664HL4, 00000086995HL8, 00000087931HL2, 00000085049HL5, 00000086175HL7, 00000084111HL4, 114184HL5, 120817HL2, 00000083003HL4, 00000105462HL6, 00000079111HL1, 00000112109HL4, 00000083603HL1, 00000084151HL0, 00000084171HL8, 00000081694HL2, 00001029933WK7, 00000079560HL9, 00000087919HL7, 00000108116HL5, 00000096596HL2, 00000325458GE8, 00001030241WK2, 00000095355HL4, 00000097743HL9, 00000097759HL5, 00000081818HL7, 00000097753HL8, 00001027880WK2, 00001030029WK1, 00000098635HL6, 00000002797EN9, 00000002799EN5, 00000002798EN7, 00000002796EN1, 00000080688HL5, 00001027351WK4, 00000084270BT8, 00000082570BT3, GEGR3740, 00000098203HL3, 00000088763HL8, 00000101694HL8, 00000076788HL9, 109407hl7, 00001034056WK0, 00001033894WK5, 00001032408WK5, 00001029037WK7, 00000086363HL9, 00001028120WK2, 00000127681HL5, 00000121191HL1, 00000092627HL9, 00000082466HL4, 00000089491HL5, 00000087896HL7, 00000097751HL2, 00001036825WK6, 00001031032WK4, 00000104930HL3, 00000096595HL4, 00000100429HL0, 00000100419HL1, 00000100424HL1, 00000083616HL3, 00000082251HL0, 00000081488HL9, 00000098196HL9, 00001028218WK4, 00000081803HL9, 00000101975HL1, 00001028287WK9, 00000087914HL8, 00000082211HL4, 00000105793HL4, 00000090220HL5, 00000081494HL7, 00000088683HL8, 00000085660HL9, 00000120198HL7, 00000081163HL8, 00001033077WK7, 00001033080WK1, 00001034448WK9, 00000112149HL0, 00001035829WK9, 00001032573WK6, 00001032620WK5, 00001032663WK5, 00001032713WK8, 00001032714WK6, 00001032715WK3, 00001032766WK6, 00000081825HL2, 00000106061HL5, 00001033086WK8, 00001036454WK5, 00001033406WK8, 00001036471WK9, 00001031657WK8, 00001033144WK5, 00001033076WK9, 00000128424BT9, 00001034555WK1, 00001033779WK8, 115241HL2, 00000081691HL8, SH2014-0971, 00000078488HL4, 00000081692HL6, 00000087852HL0, 00000087854HL6, 450173GE0, 1027263WX1, 00001027061WK9, 122201HL7, 00000079929HL6, 00000080778HL4, 00000091755HL9, 00001031401WK1, 00000078318HL3, GEGR3979, 1034621WK1, 00000117431HL7, 00000117861HL5, 00000121190HL3, 00000122258HL7, 00000122259HL5, 122218HL1, 00000098622HL4, 106699HL2, 00000117194HL1, 00000100428HL2, 00000104910HL5, 00000087758HL9, 113167HL7, 00000088680HL4, 118290HL6, 118450HL6, 118681HL6, 120653HL1, 120646HL5, 00000112124HL3, 00000112129HL2, 115227HL1, 112129HL2, 114146HL4, 115228HL9, 114087HLO, 113111HL9, 113179HL6, 1034084WK2, 00000081485HL5, 10541HL8, 00000105461HL8, 00000080784HL2, 00000092396HL1, 00000100436HL5, 00000098634HL9, 00000084414HL2, 00000087907HL2, 0000092060HLK3, 00000086366HL2, 00000088764HL6, 00000088707HL5, 00000087900HL7, 00000136553BT5, 00001034133WK7, 00000119133HL7, 00000122918HL6, 00000124484HL7, 00000125024HL0, 00000404460GE8, 00000124199HL1, 00000117178HL4, 00000124202HL3, 00000120659HL8, 1036147WK5, 00000118674HL1, 00000113155HL6, 00000113162HL2, 00000117422HL6, 00000115783HL3, 00000120194HL6, 00000115505HL0, 00000115769HL2, 00000118463HL9, 1034134WK5, 1034153WK5, 00000118264HL1, 00000118263HL3, 00000118279HL9, 1036574WK0, 00000122928HL5, 00000079625HL0, 00000114176HL1, 00000111418HL0, 00000115503HL5, 00000116644HL6, 00001035434WK8, 00000124485HL4, 00000111925HL4, 00000122919HL4, 00000118549HL5, 00000128177HL3, 00000108562HL0, 00001034700WK3, 00000122903HL8, 00000120199HL5, 00000122935HL0, 00000117428HL3, 00000118548HL7, 00000118283HL1, 00000120196HL1, 00000122913HL7, 00000117416HL8, 00000137388BT5, 1036573WK2, 00001034636WK9, 00000107454HL1, 00001030160WK4, 00001034665WK8, 00001035314WK2, 00000087097HL2, 00000093369HL7, 00001030968WK0, 00000101070HL1, 00001035077WK5, 00001035117WK9, 00000118274HL0, 00000106687HL7, 00001031286WK6, 00001031337WK7, 00001028285WK3, 00001028536WK9, 00001028898WK3, 00000084921HL6, 00000087915HL5, 00000082734HL5, 00000080686HL9, 00000098179HL5, 00000100177HL5, 00000081881BT5, 00000083338HL7, 00000119757HL3, 00000098187HL8, 00000096577HL2, 00001030212WK3, 00000095352HL1, 00000081804HL7, 00000083605HL6, 00000084185HL8, 00000455959GE8, 00001030915WK1, 00000128182HL3, 00000127954HL6, 00000092944HL8, 00001029378WK5, 00001030845WK0, 00001030952WK4, 00001028286WK1, 00001033607WK1, 00000082208HL0, 00001027445WK4, 00000100169HL2, 00000098212HL4, 00001029675WK4, 00001029697WK8, 00001029069WK0, 00001029737WK2, 00001029696WK0, 00001028980WK9, 00001028979WK1, 00000089134HL1, 00000089860HL1, 00000090977HL0, 00000090972HL1, 00000086378HL7, 00000092388HL8, 00000116638HL8, 00000117866HL4, 00000077722BT7, 00000090976HL2, 00000081807HL0, 00000081808HL8, 00000360203GE4, 00000109098BT4, 00000149409BT5, 00000086992HL5, 00000104943HL6, 00000081795HL7, 00000082482HL1, 00000082735HL2, 00000082720HL4, 00000091399HL6, 00001031287WK4, 00001030796WK5, 00001030669WK4, 00000123729HL6, 00000120658HL0, 00000122011HL0, 00000124497HL9, 00000124197HL5, 00000120651HL5, 00000124196HL7, 00000123727HL0, 00000120197HL9, 0000000015B150, 0000000015B452, 00000122217HL3, 00000118275HL7, 00000121215HL8, 00000122944HL2, 00000082747HL7, 00000104579HL8, 00000098175HL3, 00001029861WK0, 00000117433HL3, 00000111423HL0, 00001033545WK3, 00000108583HL6, 00000123736HL1, 00000124504HL2, 00000123735HL3, 00000093378HL8, 00000124168HL6, 00000088759HL6, 00000120185HL4, 00000124995HL2.00000096825HL5, 00000099172HL9, 00000089139HL0, 00000098198HL5, 00000091049HL7, 00000089135HL8, 00001035075WK9, 00001035119WK5, 00001035228WK4, 00001035181WK5, 00001035187WK2, 00000087858HL7, 00000087889HL2, 00000104511HL1, 00000105798HL3, 00001027149WK2, 00001027259WK9, 00000112136HL7, 101291HL3, 00000086178HL1, 85024HL8, D3S141095, 00001033075WK1, 00001029446WK0, 00001033091WK8, 00001031506WK7, 00001030286WK7, 00001032135WK4, 00001029054WK2, 00001033177WK5, 00001029373WK6, 00001029040WK1, 00001029163WK1, 00001029442WK9, 00001029595WK4, 00001029374WK4, 00001030801WK3, 00001030809WK6, 00001030810WK4, 00001030811WK2, 00001030840WK1, 00001030841WK9, 00001034761WK5, 00001034782WK1, 00001031119WK9, 00001031170WK2, 00001030284WK2, 00001031465WK6, 00001032574WK4, 00001029523WK6, 00001033661WK8, 00001028989WK0, 00001031571WK1, 00001031649WK5, 00001031652WK9, 00001031654WK5, 00001030562WK1, 00001032604WK9, 00001033038WK9, 00001029787WK7, 00001032681WK7, 00001032684WK1, 00001032682WK5, 00000108551HL3, 00000108552HL1, 00001031336WK9, 00001033079WK3, 00000082241HL1, 00000100191HL6, 00000098220HL7, 00001030842WK7, 00001029650WK7, 00001032493WK7, 00001032494WK5, 00001031011WK8, 00001034242WK6, 00000096821HL4, 00000077773HL0, 00000077254HL1, 00000090603HL2, 00001028066WK7, 00001034502WK3, 00001034384WK6, 00001034440WK6, 00000122231HL4, 00001033657WK6, 00000100188HL2, 00000112132HL6, 00000107447HL5, 00000083602HL3, 00000102087HL4, 00000100181HL7, 00000090234HL6, 00000085916HL5, 00000090607HL3, 00000116629HL7, 00000106053HL2, 00000089869HL2, 00000107157HLO, 00000359514GE7, 00001029701WK8, 00000117851HL6, 00000111415HL6, 00000110671HL5, 00000128415BT7, 00000102075HL9, 00000313283GE4, 00000104576HL4, 00000111421HL4, 00000104581HL4, 0000000014E825, 00000086845HL5, 00000077778HL9, 00000096819HL8, 00001033784WK8, 00000103013HL9, 00000101973HL6, 00000100180HL9, 00000103005HL5, 00000103623HL5, 00000103007HL1, 00000103003HL0, 00000103010HL5, 00000103788HL6, 00000102996HL6, 00000100738HL4, 00000099196HL8, 00000101073HL5, 00000097760HL3, 00000097752HL0, 00000084737HL6, 00000085910HL8, 00000084428HL2, 00001030926WK8, 00000087906HL4, 00000095382BT8, 00001029620WK0, 00000096808HL1, 00000096593HL9, 00000102076HL7, 00000103009HL7, 00000100182HL5, 00000103626HL8, 00000103008HL9, 00000102541HL0, 00000102546HL9, 00001032701WK3, 00000104919HL6, 00000104925HL3, 00000122256HL1, 00000121214HL1, 00000111796HL9, 00000113145HL7, 00001031391WK4, 00001030903WK7, 00001031386WK4, 00001033451WK4, 00001033432WK4, 00001033449WK8, 00001033450WK6, 00001029948WK5, 00000088706HL7, 00001031537WK2, 00001031515WK8, 00001033440WK7, 00001033176WK7, 00000085908HL2, 00000081498HL8, 00000086183HL1, 00000085654HL2, 00000085912HL4, 00000080877HL4, 00000096583HL0, 00000083600HL7, 00000096599HL6, 00000096814HL9, 00000105800HL7, 00000108564HL6, 00001031460WK7, 00001033023WK1, 00000085002HL4, 00001028347WK1, 00001028345WK5, 00001029743WK0, 00001028562WK5, 00000099198HL4, 00000106052HL4, 00000084916HL6, 00001034346WK5, 00000117191HL7, 00001030210WK7, 00001029951WK9, 00000086168HL2, 00000106073HL0, 00000086370HL4, 00000091422HL6, 00000087898HL3, 00000084726HL9, 00000110519HL6, 00000109439HL0, 00000110096HL5, 00000107452HL5, 00000097756HL1, 00000104922HL0, 00000084418HL3, 00000087104HL6, 00000085668HL2, 00000100305BT2, 00000112121HL9, 00000087920HL5, 00000082202HL3, 00000084998HL4, 00001030206WK5, 00001028852WK0, 00000107466HL5, 00000106840HL2, 00000107158HL8, 00000104921HL2, 00000105803HL1, 00000106697HL6, 00000106081HL3, 00000106069HL8, 00000102077HL5, 00000117193HL3, 00000081805HL4, 00000081800HL5, 00001030218WK0, 00000099177HL8, 00001033473WK8, 00001033495WK1, 00001033478WK7, 00001033477WK9, 00001032990WK2, 00001033476WK1, 00001033020WK7, 00001033491WK0, 00001033452WK2, 00001033474WK6, 00000085050HL3, 00000091429HL1, 00000087098HL0, 00001029685WK3, 00001028621WK9, 00001033439WK9, 00001033456WK3, 00001033457WK1, 00001033453WK0, 00001033464WK7, 00000108572HL9, 00000109428HL3, 00000119084HL2.109393HL9, 1890073, 00000096584HL8, 00000107453HL3, 00000110697HL0, 00000110700HL2, 00000112083HL1, 00000110714HL3, 00000110673HL1, 00000112085HL6, 00000107162HL0, 00000109424HL2, 00000111926HL2, 00000109431HL7, 00000109408HL5, 00000111407HL3, 00000087762HL1, 00001030588WK6, 00000088648HL1, 00000113143HL2, 00000082467HL2, 00000121114HL3, 00001029677WK0, 00000081154HL7, 00001030209WK9, 00000122012HL8, 00000114173HL8, 00000UA46748-6, 00000UA46777-2, 00000UA46778-6, 00000115778HL3, 00000115801HL3, 83012HL5, 100179HL1, 98914HL5, 100198HL1, 100197HL3, 98910HL3, 00000098636HL4, 1033181WK7, 101697HL1, 88682HL0, 80632HL3, 1033021WK5, 81683HL5, 00001031519WK0, 00000110099HL9, 00000142358BT1, 00001035328WK2, 00000116641HL2, 00000117434HL1, 00000109409HL3, 00000117843HL3, 00000117880HL5, 00000117868HL0, 00000118544HL6, 00001035325WK8, 00000117844HL1, 00000117426HL7, 00000118270HL8, 00000114143HL1, 00000116657HL8, 00000120669HL7, 00000084114HL8, 00000081491HL3, 0000000014M659, 00001032305WK3, 00000078496HL7, 00000082235HL3, 00000078975HL0, 00000101304HL4, 00000087924HL7, 00000121116HL8, 00000120176HL3, 00000UA46931-1, 00000076791HL3, 00000106833HL7, 00000106071HL4, 00000106834HL5, 00000092612HL1, 00000084905HL9, 00000360306GE5, 00001029067WK4, 00001033660WK0, 00000085047HL9, 00000360249GE7, 00000075963HL9, 00000148583BT8, 00000084912HL5, 00000085046HL1, 00000088703HL4, 00000078312HL6, 00000115236HL2, 00000083007HL5, 00000084915HL8, 00000108556HL2, 00000106062HL3, 00000106698HL4, 00000112138HL3, 00000106051HL6, 00000119760HL7, 00000116646HL1, 00000122909HL5, 00001033864WK8, 00001033865WK5, 00000079275HL4, 00000107449HL1, 00000118286HL4, 00000117845HL8, 00000120671HL3, 00000121180HL4, 00000086997HL4, 00000UA46891-7, 00000115488HL9, 00000122254HL6, 00000102083HL3, 00000105479HLO, 00000113141HL6, 00001032320WK2, and 00000089483HL2.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, including Washington D.C. Puerto Rico, Virgin Islands, and Guam; and the countries of Afghanistan, Albania, Anguilla, Antigua and Barbuda, Armenia, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, Ethiopia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Lebanon, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Papua New Guinea, Paraguay, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Trinidad , Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
  • 제품 설명
    GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System || Designed to generate diagnostic radiographic images.
  • Manufacturer

Manufacturer

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