Events

Device Recall Discovery XR656 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
    68966
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2291-2014
  • 사례 시작날짜
    2014-07-25
  • 사례 출판 날짜
    2014-08-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-02-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129139
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • 데이터 추가 비고
    Tomographic X-Ray System - Product Code lZE
  • 원인
    Ge healthcare has become aware of a potential safety issue involving the nylon hooks which support the flashpad" detector on the discovery xr656 wall stand systems. there have been reported incidents of detector falls, but no injuries have been reported.
  • 조치
    Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated July 25, 2014. The letter was addressed to Hospital Administrators / Risk Mangers, Managers of Radiology / Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. For questions in the USA call 800-437-1171. For other countries contact your local GE Healthcare Representative.

Device

Device Recall Discovery XR656
  • 모델명 / 제조번호(시리얼번호)
    Mfg Lot or Serial # System ID 00000098016HL9 419291DR1 00000098927HL7 954MCHM656 00000099011HL9 513MWDR2 00000099012HL7 419PERRYDR 00000099013HL5 252962ED1 00000099016HL8 419435DR 00000099440HL0 417347DPORT1 00000099441HL8 708684RAD3 00000099443HL4 708684RAD2 00000099444HL2 732840ER1 00000099445HL9 504349R8 00000099447HL5 608775XR6561 00000099448HL3 408259RMCED1 00000099846HL8 239424XR656 00000099848HL4 HSSE3D656 00000099850HL0 732840ER2 00000099851HL8 7737021555 00000100228HL6 802775RAD5 00000100230HL2 440816D656 00000100231HL0 910WAROBINSON2 00000100366HL4 334793SXR656 00000100368HL0 608775XR6563 00000100369HL8 509838RM1 00000100653HL5 303GVA656RM3 00000100654HL3 225658DR1 00000100655HL0 718240UCD 00000100658HL4 802775RAD1 00000100659HL2 610902XR656 00000101139HL4 843847TR3 00000101140HL2 765747XR656 00000101251HL7 724357ED1 00000101252HL5 281METHP656 00000101253HL3 206598UWEAST 00000101255HL8 919731XR656 00000101256HL6 518943D656 00000101257HL4 630208DR4 00000101258HL2 314768SMRM5 00000101259HL0 303GVA656RM1 00000101260HL8 949517RM3 00000101261HL6 239HPCXR1 00000101881HL1 708226XR656B 00000101882HL9 313745ER656 00000101883HL7 504349R4 00000102301HL9 804764ER2 00000102304HL3 225658DR2 00000102305HL0 509946XR656A 00000102306HL8 303GVA656RM2 00000102307HL6 248305D656RM2 00000102575HL8 770385DR1 00000102576HL6 830RHHRAD1 00000102851HL3 757736PWR1 00000102852HL1 914MSK656 00000102853HL9 504349POB1 00000103439HL6 303DHXR656 00000103441HL2 910417XR656 00000103669HL8 312996D656 00000103671HL4 801714RM2DR 00000103672HL2 504842IMR2 00000103959HL3 304429DIS656 00000103961HL9 701234XR656 00000104239HL9 979SJRHCRAD 00000104241HL5 517841XR656 00000104242HL3 808QMCER 00000104243HL1 713792XR3656 00000104709HL1 850505NH656 00000104711HL7 816234COPC2 00000104712HL5 XR249643 00000104713HL3 770382CER 00000104714HL1 406731MXR1 00000105160HL6 713792XR3656 00000105161HL4 419291DR2 00000105162HL2 414649XR656 00000105163HL0 314633SW 00000105165HL5 720UCHAOP2 00000105503HL7 MHXRAY1 00000105506HL0 713792XR4656 00000105507HL8 717791D656 00000106114HL2 516719ERDIG 00000106120HL9 757736RM4 00000106123HL3 936SLW656RM2 00000106124HL1 MHXRAY2 00000106673HL7 310680RM3 00000106674HL5 865541EDXR 00000106677HL8 217383EDXR2 00000106678HL6 269966XR656B 00000106968HL1 763795XR1 00000106970HL7 608258656D2 00000106974HL9 913345MDR1 00000106975HL6 808QMCRM2 00000106976HL4 830RHHRAD4 00000107176HL0 608258656D1 00000107177HL8 912920HXR656 00000107381HL6 314525656RM4 00000107383HL2 719VAMC123 00000107386HL5 217383EDXR1 00000107816HL1 915595XR656 00000107818HL7 734439XR656MAIN 00000107820HL3 412664R18 00000107821HL1 NYPAL222 00000108130HL6 DUKEURO656 00000108133HL0 815547D656 00000108134HL8 GWNT656XR1 00000108136HL3 646888XR656C 00000108703HL0 504842ORTH2 00000108709HL7 630208DER656 00000108714HL7 361694DR1 00000108722HL0 281METHSPXR 00000109569HL4 585922WILRADDR1 00000109570HL2 847570DR4 00000109987HL8 505UNMH656 00000110168HL2 646888XR656A 00000110173HL2 504873TR3D 00000110174HL0 646888XR656B 00000110428HL0 936SLW656RM1 00000110869HL5 908232D656 00000110870HL3 386FHD656 00000110877HL8 419529D656 00000103954HL4 707SSRD656 00000103956HL9 816234COPC3 00000104706HL7 254SWCHRAD1 00000105501HL1 269966XR656A 00000106125HL8 217379PXR1 00000107376HL6 828298S 00000107812HL0 757953ORTH2 00000107813HL8 313576D656B 00000108693HL3 518243ER1 00000108696HL6 4164522 00000107388HL1 GON:4180565 00000108131HL4 GON:4191836 00000108411HL0 716821OPRM2 00000108705HL5 217586G656 00000108708HL9 GON:4212438 00000108721HL2 530332XR656TR 00000109567HL8 530332XR656 00000110167HL4 GON:4180557 00000110169HL0 719VAMC124 00000110170HL8 716821OPRM1 00000110175HL7 719VAMC125 00000110432HL2 530244XR656 00000110879HL4 706544XR 00000103667HL2 217784GXR 00000105158HL0 510HCPXR656 00000105159HL8 GON: 4046606 00000107374HL1 713792FP1XR4656 00000107378HL2 707432DR3 00000108700HL6 913541ODR1 00000111354HL7 GON:1628351 00000111355HL4 GON:1628351 00000104715HL8 GON:1587706 00000108701HL4 GON:1611990 00000108712HL1 GON:4207312 00000108718HL8 GON:4191887 00000108725HL3 GON:1622072 00000109563HL7 GON:4173819 00000109566HL0 GON:4112452 00000109986HL0 GON:1611995 00000109988HL6 GON:4166880 00000109992HL8 GON:130308027 00000111371HL1 GON:1628574 00000111356HL2 GON:131496980 00000111401HL6 GON:133368920 00000112358HL7 GON:1640581 00000110172HL4 GON:1436073 00000099847HL6 83095224789 00000100365HL6 83093200335 00000109154HL5 83095135282 00000109561HL1 GON:4164862 00000108716HL2 GON:4164862 00000109564HL5 GON:4164862 00000104669HL7 GON:1000224 00000102302HL7 030392RX05 00000101250HL9 210013RX41 00000102580HL8 210013RX44 00000108720HL4 GON:41100556 00000102303HL5 GON:4157378 00000102578HL2 GON:4151792 00000103438HL8 GON:4157379 00000106972HL3 GON:4175012 00000107180HL2 GON:4157382 00000107817HL9 GON:4157381 00000109993HL6 GON:4204596 00000103668HL0 GON:4038825 00000103955HL1 GON:4038787 00000103957HL7 GON:4161140 00000104704HL2 GON:4038827 00000105156HL4 GON:4038819 00000104708HL3 GON: 4139130 00000105157HL2 GON:4038817 00000106126HL6 GON:4038781 00000110164HL1 514637RAD1 00000106122HL5 XR1032629WK6 00000105505HL2 GON:1450286 00000099014HL3 082407040509 00000099015HL0 082407040501 00000099437HL6 082407050127 00000099438HL4 082407090176 00000099439HL2 082407040507 00000099442HL6 082407050126 00000099446HL7 082407050129 00000100364HL9 082407050125 00000100656HL8 082407270123 00000101254HL1 082407040531 00000102577HL4 082407120255 00000103670HL6 082407040518 00000103675HL5 082407040514 00000104710HL9 082407070182 00000105981HL5 082407040529 00000106115HL9 082407160363 00000106119HL1 082407180093 00000106675HL2 082407040536 00000107179HL4 082407070184 00000107182HL8 082407070185 00000108137HL1 082407080108 00000108407HL8 082407080110 00000108724HL6 082407040548 00000104707HL5 082407070183 00000108694HL1 082407040539 00000107384HL0 082407070185 00000108406HL0 082407130283 00000108408HL6 082407120266 00000108695HL8 082407040538 00000108410HL2 082407070181 00000108702HL2 082407120265 00000109562HL9 082407040547 00000109565HL2 082407100511 00000110166HL6 082407100509 00000101884HL5 DK1314RX01 00000104705HL9 FI1260RX01 00000103960HL1 A5485253 00000102579HL0 D4200415 00000104238HL1 510383XR01 00000104668HL9 PC0127XR07 00000111353HL9 TP3887XR01 00000110873HL7 GON :4190435 00000110425HL6 HU1906RX01 00000100229HL4 83007000033413 00000100362HL3 83007861012013 00000099459HL0 A224857304 00000103435HL4 A54013111 00000103436HL2 A5367405 00000099003HL6 A5198035 00000103958HL5 B5368906 00000099845HL0 WB0319 00000100367HL2 WB0322 00000104244HL9 WB0002 00000104717HL4 WB0321 00000105504HL5 WB0003 00000105980HL7 WB0004 00000106121HL7 WB0331 00000106672HL9 WB0325 00000106676HL0 WB0326 00000106969HL9 WB0330 00000106973HL1 WB0324 00000107178HL6 WB0323 00000107815HL3 WB0327 00000107822HL9 WB0148 00000108132HL2 WB0329 00000108135HL5 WB0005 00000108409HL4 WB0328 00000108723HL8 WB0334 00000107181HL0 WB0006 00000108704HL8 WB0332 00000099007HL7 850070872 00000111362HL0 850070883 00000109572HL8 0850070880 or 0850070881 00000110427HL2 0850070880 or 0850070881 00000108706HL3 KW1117RX02 00000108711HL3 KW1117RX04 00000099844HL3 KW1018RX13 00000107382HL4 GON:4154389 00000110878HL6 MA1521RX03 00000099010HL1 85092575331 00000105500HL3 85105688366 00000100657HL6 NO1049RX01 00000103440HL4 NO1009RX09 00000104240HL7 NO1154RX01 00000107380HL8 NO1049RX04 00000111359HL6 NO1049RX07 00000111363HL8 Unlocated 00000111381HL0 Unlocated 00000112379HL3 Unlocated 00000113283HL6 Unlocated 00000111369HL5 Unlocated 00000108710HL5 GON:4127780 00000109990HL2 GON:4127780 00000109991HL0 GON:4127780 00000110429HL8 GON: 4127780 00000100227HL8 RU1785RX03 00000098015HL1 SA1012RX20 00000104673HL9 SA2385RX01 00000104716HL6 SA2387RX02 00000104719HL0 SA2387RX01 00000106971HL5 SA2385RX02 00000108717HL0 SA2397RX01 00000110431HL4 GON 4168426 00000099005HL1 SA1058RX18 00000099460HL8 SA1058RX12 00000100363HL1 SA1058RX13 00000107375HL8 GON:4168540 00000107377HL4 SA2061RX03 00000108413HL6 SA2394RX01 00000108697HL4 SA2061RX02 00000104718HL2 GON:4136657 00000107814HL6 GON:4168547 00000108139HL7 SF712273040PA 00000110866HL1 GON:4168533 00000110171HL6 SA2079RX06 00000108412HL8 SI4059RX03 00000106116HL7 CEZ01500 00000106117HL5 CEZ01503 00000106118HL3 CEZ01506 00000107385HL7 CEZ01512 00000107387HL3 CEZ01509 00000107819HL5 CEZ01524 00000108129HL8 CEZ01521 00000108138HL9 DEN272116 00000108707HL1 CEZ01518 00000108715HL4 CEZ01515 00000103666HL4 W009RX01 00000110165HL8 A021RX01 00000110876HL0 856070122 00000110430HL6 GON :4186541 00000099843HL5 GON:4112121 00000099849HL2 GON: 4121735 00000100232HL8 00681RAD09 00000103673HL0 00681RAD08 00000103674HL8 IE1564RX04 00000105164HL8 00529RAD05 00000105502HL9 00440RAD30 00000108405HL2 00529RAD06 00000108719HL6 10692RAD01 00000109568HL6 00490RAD10 00000109571HL0 00490RAD11 00000100233HL6 XR1031601WK6
  • 의료기기 분류등급
    Orthopedic Devices
  • 유통
    USA: AL, CA, CO, FL, GA, HI, IL, IN, KS, LA, MD,MI, MN, MO, MT, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VT, VA, WA, WV, WI. OUS: ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BERMUDA, CANADA, CHILE CHINA, DENMARK, FINLAND, FRANCE, GERMANY, HUNGARY, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, MOROCCO, NEW ZEALAND, NORWAY, PAKISTAN, RUSSIA, SAUDI ARABIA, SLOVENIA, SPAIN, SWEDEN,THAILAND, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY.
  • 제품 설명
    GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

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