Events

Device Recall GE Precision 500D 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare 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
    49467
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1610-2008
  • 사례 시작날짜
    2008-01-02
  • 사례 출판 날짜
    2008-09-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73494
  • 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
    Fluoroscopic X-Ray System - Product Code JAA
  • 원인
    Ge healthcare was notified that 2 recently installed precision 500d systems were not in compliance with portions of the performance standard for diagnostic x-ray equipment. x-ray production was possible from the fluoroscopic x-ray tube when the primary protective barrier was not in position to intercept the x-ray beam. users are recommended to follow good clinical standards to ensure the image i.
  • 조치
    A Product Safety Notification letter, dated 01/09/2008 was sent to affected customers. This letter described the safety issue, affected product and safety instructions. A GE Field Engineer will schedule a field visit to affected customers to inspect and replace the park latch switch as needed.

Device

Device Recall GE Precision 500D
  • 모델명 / 제조번호(시리얼번호)
    serial numbers: 00000004108GQ7, 00000004874GQ4, 00000006742GQ1, 00000007111GQ8, 00000008717GQ1, 00000008892GP2, 00000010136GQ0, 00000012808GP2, 00000013547GP5, 00000013737GP2, 00000013844GP6, 00000985953WK9, 00000987224WK3, 00000987333WK2, 00000989376WK9, 00012966GP8000, 00000000BRBGDM, 00000000BRBGDR, 00000000BRBUF8, 00000000BRD138, 00000000BRF490, 00000000BRF49B, 00000000BRBBXV, 00000000BRBL7V, 00000000BRETRE, 00000986515WK5, 00000097958WK2, 000000980212WK, 00000098186WK0, 00000098235WK4, 00000098734WK5, 00000970756WK3, 00000971704WK2, 00000972504WK5, 00000972505WK2, 00000972772WK8, 00000973070WK6, 00000973500WK2, 00000973502WK8, 00000973616WK6, 00000973617WK4, 00000973618WK2, 00000973624WK0, 00000973883WK2, 00000973884WK0, 00000973885WK7, 00000974085WK3, 00000974087WK9, 00000974410WK3, 00000974411WK1, 00000974412WK9, 00000974445WK9, 00000974446WK7, 00000974447WK5, 00000974676WK9, 00000974677WK7, 00000974678WK5, 00000975166WK0, 00000975167WK8, 00000975169WK4, 00000975171WK0, 00000975172WK8, 00000975626WK3, 00000975627WK1, 00000975628WK9, 00000975629WK7, 00000975630WK5, 00000975631WK3, 00000975632WK1, 00000975946WK5, 00000975947WK3, 00000975948WK1, 00000975949WK9, 00000975958WK0, 00000975959WK8, 00000975960WK6, 00000975961WK4, 00000975962WK2, 00000975964WK8, 00000977046WK2, 00000977047WK0, 00000977048WK8, 00000977049WK6, 00000977050WK4, 00000977051WK2, 00000977052WK0, 00000977053WK8, 00000977054WK6, 00000977055WK3, 00000977233WK6, 00000977234WK4, 00000977236WK9, 00000977238WK5, 00000977239WK3, 00000977853WK1, 00000977854WK9, 00000977855WK6, 00000977857WK2, 00000977858WK0, 00000977859WK8, 00000977860WK6, 00000977861WK4, 00000978079WK2, 00000978080WK0, 00000978082WK6, 00000978083WK4, 00000978084WK2, 00000978085WK9, 00000978086WK7, 00000978485WK1, 00000978486WK9, 00000978487WK7, 00000978488WK5, 00000978489WK3, 00000978490WK1, 00000978491WK9, 00000978492WK7, 00000978493WK5, 00000978494WK3, 00000978715WK1, 00000978716WK9, 00000978826WK6, 00000978827WK4, 00000979056WK9, 00000979057WK7, 00000979083WK3, 00000979084WK1, 00000979097WK3, 00000979125WK2, 00000979126WK0, 00000979150WK0, 00000979151WK8, 00000979206WK0, 00000979207WK8, 00000979227WK6, 00000979228WK4, 00000979256WK5, 00000979257WK3, 00000979380WK3, 00000979381WK1, 00000979388WK6, 00000979389WK4, 00000979390WK2, 00000979391WK0, 00000979448WK8, 00000979449WK6, 00000979450WK4, 00000979466WK0, 00000979467WK8, 00000979468WK6, 00000979469WK4, 00000979516WK2, 00000979517WK0, 00000979518WK8, 00000979584WK0, 00000979638WK4, 00000979639WK2, 00000979640WK0, 00000979641WK8, 00000979691WK3, 00000979692WK1, 00000979693WK9, 00000979827WK3, 00000979828WK1, 00000979894WK3, 00000979895WK0, 00000979896WK8, 00000979897WK6, 00000979898WK4, 00000979941WK2, 00000979942WK0, 00000979944WK6, 00000979945WK3, 00000980041WK8, 00000980042WK6, 00000980043WK4, 00000980044WK2, 00000980045WK9, 00000980183WK8, 00000980213WK3, 00000980317WK2, 00000980318WK0, 00000980319WK8, 00000980321WK4, 0000098032OWK6, 00000980423WK8, 00000980424WK6, 00000980425WK3, 00000980426WK1, 00000980427WK9, 00000980612WK6, 00000980613WK4, 00000980614WK2, 00000980615WK9, 00000980616WK7, 00000980695WK1, 00000980696WK9, 00000980746WK2, 00000980747WK0, 00000980748WK8, 00000980845WK2, 00000980846WK0, 00000980847WK8, 00000980848WK6, 00000980849WK4, 00000980937WK7, 00000980938WK5, 00000980939WK3, 00000980941WK9, 00000980942WK7, 00000980943WK5, 00000980944WK3, 00000980945WK0, 00000980946WK8, 00000981214WK0, 00000981215WK7, 00000981216WK5, 00000981217WK3, 00000981218WK1, 00000981354WK4, 00000981355WK1, 00000981361WK9, 00000981362WK7, 00000981363WK5, 00000981364WK3, 00000981368WK4, 00000981369WK2, 00000981370WK0, 00000981371WK8, 00000981372WK6, 00000981520WK0, 00000981521WK8, 00000981523WK4, 00000981524WK2, 00000981717WK2, 00000981718WK0, 00000981719WK8, 00000981720WK6, 00000981721WK4, 00000981722WK2, 00000981723WK0, 00000981724WK8, 00000981725WK5, 00000981726WK3, 00000981861WK8, 00000981862WK6, 00000981863WK4, 00000981864WK2, 00000981865WK9, 00000981866WK7, 00000981867WK5, 00000981868WK3, 00000981869WK1, 00000982053WK1, 00000982054WK9, 00000982055WK6, 00000982056WK4, 00000982058WK0, 00000982059WK8, 00000982061WK4, 00000982062WK2, 00000982159WK6, 00000982160WK4, 00000982161WK2, 00000982162WK0, 00000982163WK8, 00000982164WK6, 00000982165WK3, 00000982166WK1, 00000982167WK9, 00000982359WK2, 00000982360WK0, 00000982361WK8, 00000982362WK6, 00000982363WK4, 00000982364WK2, 00000982365WK9, 00000982366WK7, 00000982367WK5, 00000982521WK7, 00000982522WK5, 00000982523WK3, 00000982524WK1, 00000982525WK8, 00000982631WK4, 00000982632WK2, 00000982633WK0, 00000982634WK8, 00000982635WK5, 00000982636WK3, 00000982637WK1, 00000982638WK9, 00000982840WK1, 00000982841WK9, 00000982842WK7, 00000982843WK5, 00000982845WK0, 00000982846WK8, 00000982847WK6, 00000982848WK4, 00000982849WK2, 00000983022WK5, 00000983023WK3, 00000983024WK1, 00000983025WK8, 00000983026WK6, 00000983027WK4, 00000983028WK2, 00000983030WK8, 00000983031WK6, 00000983317WK9, 00000983318WK7, 00000983319WK5, 00000983320WK3, 00000983321WK1, 00000983322WK9, 00000983323WK7, 00000983324WK5, 00000983325WK2, 00000983326WK0, 00000983629WK7, 00000983734WK5, 00000983735WK2, 00000983799WK8, 00000983800WK4, 00000983801WK2, 00000983802WK0, 00000984048WK9, 00000984049WK7, 00000984050WK5, 00000984051WK3, 00000984052WK1, 00000984053WK9, 00000984054WK7, 00000984055WK4, 00000984056WK2, 00000984057WK0, 00000984347WK5, 00000984348WK3, 00000984349WK1, 00000984350WK9, 00000984351WK7, 00000984352WK5, 00000984355WK8, 00000984356WK6, 00000984769WK0, 00000984770WK8, 00000984771WK6, 00000985469WK6, 00000985471WK2, 00000985472WK0, 00000985473WK8, 00000986121WK2, 00000986122WK0, 00000986123WK8, 00000986124WK6, 00000986166WK7, 00000986167WK5, 00000986168WK3, 00000986169WK1, 00000986306WK9, 00000986307WK7, 00000986308WK5, 00000986309WK3, 00000986310WK1, 00000986438WK0, 00000986439WK8, 00000986440WK6, 00000986441WK4, 00000986447WK1, 00000986448WK9, 00000986449WK7, 00000986450WK5, 00000986451WK3, 00000986564WK3, 00000986565WK0, 00000986566WK8, 00000987038WK7, 00000987039WK5, 00000987041WK1, 00000987042WK9, 00000987043WK7, 00000987044WK5, 00000987045WK2, 00000987046WK0, 00000987047WK8, 00000987639WK2, 00000987640WK0, 00000987641WK8, 00000987642WK6, 00000987643WK4, 00000987961WK0, 00000987962WK8, 00000987963WK6, 00000987964WK4, 00000987965WK1, 00000988158WK2, 00000988159WK0, 00000988160WK8, 00000988161WK6, 00000988162WK4, 00000988616WK9, 00000988617WK7, 00000988618WK5, 00000988619WK3, 00000988620WK1, 00000988621WK9, 00000988622WK7, 00000988623WK5, 00000988983WK3, 00000988984WK1, 00000988985WK8, 00000988986WK6, 00000988987WK4, 00000988988WK2, 00000988989WK0, 00000989175WK5, 00000989568WK1, 00000989569WK9, 00000989570WK7, 00000989571WK5, 00000989572WK3, 00000989573WK1, 00000989574WK9, 00000989575WK6, 00000989576WK4, 00000989577WK2, 00000989801WK6, 00000989802WK4, 00000989803WK2, 00000989804WK0, 00000989805WK7, 00000989887WK5, 00000989888WK3, 00000989889WK1, 00000989890WK9, 00000989891WK7, 00000989892WK5, 00000989893WK3, 00000990070WK5, 00000990071WK3, 00000990072WK1, 00000990073WK9, 00000990074WK7, 00000990142WK2, 00000990143WK0, 00000990193WK5, 00000990784WK1, 00000990785WK8, 00000990786WK6, 00000990787WK4, 00000990788WK2, 00000990789WK0, 00000990790WK8, 00000990791WK6, 00000990792WK4, 00000990793WK2, 00000991184WK3, 00000991185WK0, 00000991186WK8, 00000991187WK6, 00000009804GP6, 00000008087GQ9, 00000106606DP7, 00000106899DP8, 00000106901DP2, 00000107312DP1, 00000001267M34, 00000001573M35, 00000002001M36, 00000002007M33, 00000003186M34, 00000003245M38, 0000000B8419JP, 00000990473WK1, 00000990475WK6, 00000991351WK8, 00000991513WK3, 00000991517WK4, 00000991520WK8, 00000991525WK7, 00000991529WK9, 00000991537WK2, 00000991538WK0, 00000992468WK9, 00000992506WK6, 00000992507WK4, 00000993566WK9, 00000995819WK0, 00000997090WK6, 00000997877WK6, 00000998406WK3, 00000998812WK2, 00000998814WK8, 00001000445WK5, 00001000446WK3, 00001000926WK4, 00001002184WK8, 00001002227WK5, 00001003777WK8, 00001005647WK1, 00000099310WK0, 00000100227WK1, 00000100464WK3, 00000108883WK9, 00000979829WK9, 00000991248WK6, 00000991249WK4, 00000991250WK2, 00000991251WK0, 00000991252WK8, 00000991254WK4, 00000991255WK1, 00000991282WK5, 00000991778WK2, 00000991827WK7, 00000991828WK5, 00000991829WK3, 00000991981WK2, 00000992023WK2, 00000992024WK0, 00000992025WK7, 00000992026WK5, 00000992027WK3, 00000992028WK1, 00000992029WK9, 00000992030WK7, 00000992031WK5, 00000992032WK3, 00000992148WK7, 00000992149WK5, 00000992150WK3, 00000992151WK1, 00000992152WK9, 00000992153WK7, 00000992154WK5, 00000992155WK2, 00000992156WK0, 00000992157WK8, 00000992431WK7, 00000992432WK5, 00000992433WK3, 00000992434WK1, 00000992435WK8, 00000992436WK6, 00000992437WK4, 00000992438WK2, 00000992439WK0, 00000992440WK8, 00000992990WK2, 00000992991WK0, 00000992992WK8, 00000992993WK6, 00000992994WK4, 00000992995WK1, 00000992996WK9, 00000992997WK7, 00000992998WK5, 00000992999WK3, 00000993109WK8, 00000993110WK6, 00000993111WK4, 00000993112WK2, 00000993665WK9, 00000993666WK7, 00000993667WK5, 00000993668WK3, 00000993671WK7, 00000993672WK5, 00000993673WK3, 00000993674WK1, 00000993957WK0, 00000993958WK8, 00000993959WK6, 00000993960WK4, 00000993961WK2, 00000993962WK0, 00000993963WK8, 00000993964WK6, 00000993965WK3, 00000993966WK1, 00000994146WK9, 00000994147WK7, 00000994148WK5, 00000994149WK3, 00000994150WK1, 00000994151WK9, 00000994152WK7, 00000994269WK9, 00000994270WK7, 00000994272WK3, 00000994273WK1, 00000994638WK5, 00000994639WK3, 00000994640WK1, 00000994641WK9, 00000994642WK7, 00000994643WK5, 00000994645WK0, 00000994788WK8, 00000994789WK6, 00000994790WK4, 00000994791WK2, 00000994792WK0, 00000994793WK8, 00000994794WK6, 00000994795WK3, 00000994796WK1, 00000994797WK9, 00000994889WK4, 00000994890WK2, 00000994891WK0, 00000994892WK8, 00000994893WK6, 00000994894WK4, 00000994895WK1, 00000994896WK9, 00000994897WK7, 00000994898WK5, 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00001010212WK7, 00001010213WK5, 00001010214WK3, 00001010215WK0, 00001010216WK8, 00001010217WK6, 00001010287WK9, 00001010328WK1, 00001010329WK9, 00001010330WK7, 00001010331WK5, 00001010333WK1, 00001010334WK9, 00001010335WK6, 00001010336WK4, 00001010337WK2, 00001010550WK0, 00001010551WK8, 00001010552WK6, 00001010553WK4, 00001010554WK2, 00001010555WK9, 00001010556WK7, 00001010739WK9, 00001010741WK5, 00001010743WK1, 00001010744WK9, 00001010745WK6, 00001010746WK4, 00001010747WK2, 00001010748WK0, 00001010854WK6, 00001010855WK3, 00001010856WK1, 00001010859WK5, 00001010860WK3, 00001010861WK1, 00001010862WK9, 00001010863WK7, 00001011010WK4, 00001011011WK2, 00001011012WK0, 00001011013WK8, 00001011029WK4, 00001011030WK2, 00001011031WK0, 00001011033WK6, 00001011035WK1, 00001011036WK9, 00001011037WK7, 00001011200WK1, 00001011201WK9, 00001011202WK7, 00001011203WK5, 00001011204WK3, 00001011205WK0, 00001011206WK8, 00001011207WK6, 00001011208WK4, 00001011209WK2, 00001011320WK7, 00001011321WK5, 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00001012188WK7, 00001012189WK5, 00001012190WK3, 00001012191WK1, 00001012192WK9, 00001012193WK7, 00001012194WK5, 00001012195WK2, 00001012432WK9, 00001012434WK5, 00001012435WK2, 00001012499WK8, 00001012500WK3, 00001012501WK1, 00001012502WK9, 00001012503WK7, 00001012505WK2, 00001012506WK0, 00001012508WK6, 00001012541WK7, 00001012542WK5, 00001012543WK3, 00001012546WK6, 00001012547WK4, 00001012548WK2, 00001012549WK0, 00001012881WK7, 00001012883WK3, 00001012884WK1, 00001012885WK8, 00001012888WK2, 00001012889WK0, 00001012991WK4, 00001012992WK2, 00001012993WK0, 00001012994WK8, 00001012995WK5, 00001012996WK3, 00001012997WK1, 00001012998WK9, 00001013087WK0, 00001013088WK8, 00001013089WK6, 00001013090WK4, 00001013102WK7, 00001013176WK1, 00001013177WK9, 00001013178WK7, 00001013179WK5, 00001013181WK1, 00001013182WK9, 00001013183WK7, 00001013184WK5, 00001013185WK2, 00001013293WK4, 00001013294WK2, 00001013298WK3, 00001013299WK1, 00001013301WK5, 00001013302WK3, 00001013576WK2, 00001013577WK0, 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00001015092WK8, 00001015093WK6, 00001015096WK9, 00001015219WK7, 00001015220WK5, 00001015292WK4, 00001015293WK2, 00001015295WK7, 00001015297WK3, 00001015298WK1, 00001015559WK6, 00001015562WK0, 00001015563WK8, 00010103324WK3, 00001013029WK9, and 00001013807WK1.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, Washington D.C. and Puerto Rico and OUS to include: ARGENTINA, AUSTRALIA, BRAZIL, CANADA, CHILE, DOMINICAN REPUBLIC, EGYPT, GERMANY, HONDURAS, INDIA, INDONESIA, IRELAND, JAMAICA, KOREA, KUWAIT, MALAYSIA, MEXICO, NETHERLANDS, PANAMA, RUSSIAN FEDERATION, SAUDIA ARABIA, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM,
  • 제품 설명
    GE Precision 500D, model 2288798, 2289299, 2290479, 2305472, 2305473, 2305495, 2336900, 2345243, 2401181, 2403790, 2403791, 2404103, 2407276, 2407576, 5179385, 2289299-2, 2290479-2, 2345260-12, 2345260-3, 2403790-3, and 2403791-3, GE Medical Systems - Americas: Milwaukee, USA. The device is used to perform fluoroscopic examination of human anatomy.
  • Manufacturer
    GE Healthcare

Manufacturer

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