Events

Device Recall GE Innova 4100 / 4100 IQ Fluroscopic xray system 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
    49105
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2438-2008
  • 사례 시작날짜
    2008-07-25
  • 사례 출판 날짜
    2008-09-20
  • 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=72791
  • 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
    Solid State X-Ray Imager - Product Code MQB
  • 원인
    The charger and / or battery of the pdb may fail earlier than expected with no advance warning and thus cause the system to shut down.
  • 조치
    Consignees (Hospital Administrators; Hospital Risk Management Department; Mangers of Radiology/Cardiology; Radiologists/Cardiologists) were sent a "GE Urgent Medical Device Correction" letter dated July 2008. The letter described the affected products; the problem; and the user instructions, which state that the hospital should establish emergency workflow procedures to ensure patient safety should a component stop operating during a patient examination. Facilities should verify if their system has been impacted by checking if the catalog numbers listed are referenced on the PDB panel located in the equipment room. The letter also states the GE Healthcare Resolution Plan, includes correcting the condition, and contact Information.

Device

Device Recall GE Innova 4100 / 4100 IQ Fluroscopic xray system
  • 모델명 / 제조번호(시리얼번호)
    201541SP1 2035764100 204787INNOVA1 205759CL2 209467INNOVA308 216844INNOVA 219326IN41 2194654100 229228INNOV41C 229228INNOV41V 22925941V 22925941V2 229434INNOV 239436CATH1 239939INNOVA 248849SP1 250370INNOVA 251435I12 251435ICV5 252816INNOVA 252847PRS2 252847PRS3 269226IN1 269226IN2 269226IN2 269983IN41 281401T4100 3016094100 3018774100 3027444100 303320OR41 303399IR 303436ANGIO 303839CL1 304255INNOVA 304255INNOVA 304256INNOVA 304347INNOVA 304347INNOVA2 304424CCINOVA 305823IN4100 305835IN41 306766INNOVA 308534ANG 309343CSP1A 309655FSP1A 309655FSP3A 309672M4100 312792R4100 313343SP1 313876SP41 314569SJRM12 314966DPHSP 315448RM4 315448RM5 316651INNOVA41 316962INNOVA41 317338PV3 317887INNOVAPV 3184734100 319338VA4100 325670CATH 330489SPEC9 334286BSP 337981INNOVA 352333INVOR 352333VASC 352376SP 352401CATH 352401VASC 352596SPEC 360754INNOVA 386254HS1 386254HS2 386HPOS1 401274IN41 404466SF41A 404616INNOVA 404GHSIR1 404GHSIR2 407518SP2 407518SP3 407SPECIALS 4082594100 409212INOV41 4103374100 410337INNOVA2 4105434100 412623LAB1 412623LAB3 412647OR10 412784LAB1 412784LAB2 4134474100 4135344100 4137484100 414328INN4100 414649CL2 414649DVI 414961INN4100 4163694100 416756INNOVA 419251LAB1 419557ORLAB 419696LAB1 423493I4100 423495ENDO2 423495M4100E 423495MSPEC2 4438494100 478633INOV 478765ANG1 480512SP 5033704100 505848CATH2 505848V4100 508383IN4100 508650IN41 508856OR41 5094744100 509474SH41 509482HFI 509575YM4100 512528CPCL1 512901NI4100 5134754100 5135844100 5136864100 5136864100 5138534100 514376INNOVA 514842AINNOVA 514934BANGIO 515263IL4100 516562INNOVA4 519663INNOVA2 519685INNOVA 530888ANG206 541282CV2 541686SPR1 5417684100 561548VAS2 561694IN1 561747IN4 561776IN41 561784INSP 5703214100 570321LAB2 5705224100 573632CRA 573761SMA 574294IN41 574535IN41 574647IN2 574647IN41 574647IN41 586573SP1 6012884100SP1 601376SP4100 6029234100 603650ANG1 604557INNOVA 605333RM10 606833INNOVA 6082634100 608263ACT 608263XMR 608324DAL 609652CATH3 609652CATH3 610954INNOVA41 610954INNOVA41 610988INNOVA4 613548INNOVA3 614293LIBERTY1 614293LIBERTY2 615284OR15 617525IN1 617636IN1 617726RF2Y6 618549CM4100 619229INNOVA1 620665INNOVA41 623848SP 626359INNOVA 630275G41 630275G41B 6309784100 650369SV5 650493ANGIOCT 6616324100 662244GTSP 678EJCIR1 7023604100 7028804100 704487CR41 706278INNOVA1 706291RINN 706291RINN2 706651SP1 706733SP1 706774USP3 706802FINN 708202VA41 7087564100 708783CL4100 708783SP4100 708WESTSUB4100 713375U4100 7137764100 715369INN4100 717763INNOVA41 717763OR4100 718206LIBERTY1 718250ANGIO 718518CVL1 718630LIBERTY 719560INN41 724656ANG 727398SPEC1 727725SPEC1 727791INNOVA 727819SPSC 740592INNOVA 757398INNOVA 757736INNOVA 757736INNOVA 757889INNOVA 757889INNOVA 760633IR1 770535N4100 770736SP1 773878SWGANGIO1 77573841 801268INNOVA 80140841 8014794100 80158241 80180741 802295VALCA 803256SP 803329CL41 804285CATH2 804320CATH2B 804594ANGIO 804594CATH 804764CATH3 810342A41 812238UN41 812279INNOVA1 812825INNOVA1 812858GWSP 813558INTV 813615CL10 813745INTV 813972INTV 815740SC4100 8159374100 816276SP1 816943SP1 817255NH4100 817433HSW4100 817465AR4100 817922BA4100 828298VASC 828696IN41 843577CL2 843674VAS1 843797TIR2 845368RM10 8458584100 847842GS4100 850494WSP1 850494WSP1 850747IN4100 856365ANGIO 8593134100 8595724100 863687INV24 864255SF4100 864573LAB2 865373SP 865481SUR 865541CCL5 865693CCL3 901726SP2 903CSM4100 903GS4100 904202SP1 904276SP 904BSSP 908522SP1 913317SLS4100 915577SP1 918307SHIN4 918682IN41 918744JC4100 918744JR4100 918744JR4100 9408984100 941483INNOVA41 952993INNOVA2 954MW4100 956632INN4100 970247INNOVA 972335LIB 972487ANGIO1 972566INNOVA3 985867INNOVA2 989466INNOVA COR359867 DR4100 ECXV1406E ECXVINNOVARST3 FHORL4100 FWANG3217 MCL4100 MIRAMAR41 PEMBROKE4100 RADNETXV1 RADNETXV2 RHD4100 SLIN4100 WCATHLAB41 2515139 0002520549A 2574392 2650620 2667650 2670537 2677299 2680596 2683976 2697900 2698692 2701519 2705539 2710199 2712110 2712111 2713221 2718141 2722283 2729637 2730844 2733412 2733723 2740431 2741400 2741459 2741764 2742712 2742719 2743706 2744276 2744293 2744745 2745129 2745685 2745844 2746655 2750142 2750583 2753604 2754920 2756873 2757398 256429SV1 317621PV 318681INNOVA1 6012884100SUR 609757IN4100 731541XA1 904202SP2 906485ANGIO ECXVINNOVARST1 ECXVINNOVARST2, and ECXVINNOVARST4
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution --- including states of CA, FL, NY, AK, AL, AR, AZ, PA, FL ,CO, SC, CT, IA, DC, DE, GA, HI, IL , IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NJ, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and GUAM.
  • 제품 설명
    Innova 4100 / 4100 IQ , GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) || Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. Also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. Intended to replace fluoroscopic images obtained through image intensifier technology.
  • 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