Events

Device Recall GE Innova 2100IQ 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-2436-2008
  • 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=72789
  • 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 2100IQ Fluroscopic xray system
  • 모델명 / 제조번호(시리얼번호)
    201447LAB1 202782LABC 2035762100 208227CATH1 208367INNOVA 208381CCL1 212305CATH1 212604INNOVA1 214947MINNOVA 214947MINNOVA2 215453INNOVA21 217383CCL2A 219932DCL2 229228INNOV21C 239436CATH4 251435ICV3 251435ICV7 252384CATH1 253627INNOVA1 262255INNOVA2 262255INNOVA2 262687CL2 303369HCL4 303425CL3 303788CL1 303839CL2 304424INNOVA 305364P2100 305682IN2 308865GIN1 310825INNOVA21 317355INNOVA3 318448INNOVA3 330363LAB3 330375LAB2 336538ARCL 336832MCCL6 360456XCL4 402559UCC 402559UCD 405604D2100 408559INV1 409938INV21 410337INNOVA6 410554INNOVA1 410554INNOVA2 410554INNOVA3 410554INNOVA4 4107872100 412367LAB2 414291CL2 414649INNOVA2 416480INNOVA 416864INNOVA 416864INNOVA2 417269SCLA 417347FCV2 417347FCV4 423495MCATH1 4436432100 501257VALAB1 505848CATH1 505848EP 508335INNOVA 508856IN21 508941IN21 509575YM2100 516562INNOVA2A 516562INNOVA6 516562INNOVA7 516632INNOVA1 518243LAB1 518243LAB2 541732CV2 541743CL3 561548ET2 570476INNOVA21 573256MHC 573761SMC2 573815BCR2 573815BCR3 573815BCR4 574535IN21 602239CLAB2 604682INNOVA1 604682INNOVA2 604875AINNOVA1 604875AINNOVA2 607737CL1 608775NOVA1 608775NOVA2 610250INNOVA1 610250INNOVA3 610776INNOVA21 610983INNOVA2 612273INNOVA2 615284CV3 615342CV3 615446CV1 615515OPCL 617636CL1 619457INNOVA6 619552INNOVA2 630856H2100 650369SV4 65049321 651582IN3 661327INNOVA1 661327INNOVA2 7023602100 704384CL21 706291CLIN1 713375U2100 713794LAB1 717217INN21 717544GECATH2 717544GECATH3 718470EP 718780CATH3 727521CATH2 727521CATHOP 727869CATH3 727869CCL2 727869EP5 727942CATH2 732324INN1 732776CATH4 732923INN 770HMCCL1 775982INN2100 781340IN1 781340IN3 785354HRTEP 803256PCL5 804764CATH2 8053702100 808547QCV1A 808547QCV3A 812238UN21 813615CL1 813615CL8 813615CL9 813615EP3 814452EP 8157412100 815759CARDIAC1 816861KCVAI2 817329BG2100 8184092100 828213IN21 843692CATH3 843724CL1 843724CL2 843724CL3 843724EP1 843797EP 843797TCL1 845365V13 845368LAB1 845368LAB2 847316INNOVA1 847316INNOVA2 856853IN2100 857307IN421 858554INNOVA2 858554INNOVA3 864255SFCL1 864255SFCL2 865693CCL 865693CCL2 865977CCL 901765EP 904597CATH 905848INNOVA1 910343EP1 910343EP2 910671INOV21 916781INNOVA2 9284532100 937208INNOVA2 949250I21 954735CL2 954987CCL7 954987CCL8 954987CL4 970350CL2 9704CHINNOVA 973579LAB1 985898INNOVAA 985898INNOVAB CM2100 ECXV1406F FHOMEP LVINOV7 PRESBYDEP RPINNOVA2100 2637041 2680771 2683172 2686112 2706718 2710562 2713664 2713687 2715023 2718602 2729712 2730402 2730405 2730406 2731313 2731570 2731573 2731583 2738012 2741780 2749861 2754702 2755150 2756171 262687CL1 316689MP 541677MINNOVA2 541789CV1 609267IN2100 609757IN2100 610645LAB10 760940INNOVA2, and 828315FIN2
  • 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 2100IQ (The Digital Fluoroscopic Imaging 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