Events

Device Recall GE Innova 3100 / 3100 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-2437-2008
  • 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=72790
  • 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 3100 / 3100 IQ Fluroscopic xray system
  • 모델명 / 제조번호(시리얼번호)
    2652143 2014183100 201541LAB2 201996LAB1 2035763100 2035763100A 2036883100 205783BCL5 205877CCL1 205877CCL2 207351YCL1 207662CL4 207879CL131 208227CATH2 209334LINNOVA1 214324INNOVA2 214590PH3100 215335INNOVA1 215576INNOVA1 219326IN31 2197573100 219877IN2 219877IN31 228818VASC 239436CATH3 239513CRLAB1 239939CLA 251435ICV6 251633PROV 253968INNOVA 254742KDCL1 262687CL3 270688INN 281420LAB1 281420LAB23100 281440CL3 3027443100 303425CL4 303629CL4 303629EP 303788CL2 305364P3100 308865GIN2 309691P3100 310319SM3100 310423INNOVA1 310825INNOVA31 312STMNAZ3100 313593IC1 313593IC2 314525STACL2 314768SMCL1A 314768SMCL3 316268INNOVAA 316651INNOVA31 316962WCVC1 316962WCVC2 318448INNOVA2 318449INNOVA2 318798CL1 325428CATH1 325428CATH3 334418CL 336832MCPV 337374INNOVA 352333CATH1 352333CATH2 360456XCL3 361857CATH1 361980INNOVA2 402559UCB 404686CRI3 405272SCL2 405372S3100 405604D3100 405610NW3100 405840OIC3100 406447VAIN3 406543IN3 409899LAB3 4103323100 4103623100 412437INNOVA 413447CATH 413540IN1 413582C3100 414447CL1 414647CL1 414649CL3 414649CL4 414805INNOVA1 415925INV1 417269SCLD 417347FCV5 417885JCL7 417885JCL8 423495MCL6 423844CCL1 478274CTH1 479441SP3100 480728LAB2 480821IN2 502587LAB1 502587LAB4 502852INNOVA 5033703100 5034353100 507385INN3100 508856IN2 508941IN1 509946CATH2 510797INV8 512901NI3100 516562INNOVA8 516562INNOVA9 516632INNOVA2 516663INNOVA1A 516663INNOVA2 518525LAB1 530244XC106 540953INNOVA 541382CV3 541677MINNOVA1 541743CL6 541MWHINNOVA 561266IN31 561548CL4 570476INNOVA31 573458CL1 573632CRC2 573815BCR1 573882UMC1 580548B3100 6012883100CV2 601553CL3 601883CL1 602239LAB4 602239LAB6 602266LAB2 603421PCL 603580ECL1 608524NOVA 609757IN3100 610447CL1 610526LAB1 610526LAB2 610595CL1 6106483100 610770INNOVA31 610891CL1 610954INNOVA1 610983INNOVA1 615338CV2 615769SKYCV2 616392INNOVA 617732IN9 617789IN1 618241GSI3100 619340VA8 619457INNOVA5 619482INNOVA1 619541INNOVA31 619552INNOVA1 620225INNOVA31 630312B31 630856H31 631376EP 631968INNOVA2 631968INNOVA3 650369SV3 65049331 6619483100 662377CV2 662377CV4 671GMHAINVA 678957INNOVA 7018573100 7022333100 702616INNOVA 7028533100 7028803100A 704355RM2 704384CATH2 704384PHMCATH 704878CL31 706481CCL 706774CCL4 706774CCL5 7083333100 708WESTSUB3100 713359INC 713776M3100 713794LAB7 713794LAB9 713948INA 714843INNOVA 714966INNOVA 717217INN31 717782INNOVA31 717782INNOVA31A 717782INNOVA31B 718245UNITY 718250CATH1 718270INNOVA1 718283INNOVA3 718470INNOVA2 718780CATH2 724773C1 727725CATH2 7278253100 731422CV1 732294INOV 732776CATH6 760242CATH1 760242CATH2 760323DRINNOVA 765453INNOVA1 770991CL1 770991CL3 772LWCL1 773792CL3100 773NORWG3100 775982CATH2 781340IN2 785354S3100 8014793100 8019643100 803255CL1 803256PCL1 803329CL31 804285CATH1 8053703100 808547QCV2A 812238LIB1 812283IN31 812450CATH1 812450EP1 812450EP1 812482INNOVA 812858GWLAB1 812858GWLAB2 814676C1 815226INN2 815344CARDIAC3 815599FHN3100 8157413100 815756KCHSPEC 816478MC1 816861KCVAI1 816943STJIC1 816969LSCATH 816985NKCI 817433HSW3100 8184093100 8185023100 8189813100 843797TCL2 845365V19 847362CONCATH4 850469BCV1 850678IN3100 850747BR3100 850747GC3100 850862IN3100 856596IN3100 8613100 863687CL31 864255SFCL3 865481CCL2 865512CL3 865693CCL1 901516R3 903UT3100 904202CATH3 904276CTH1 904276CTH1 907562CATH1 908522LAB1 909464IN3 909788INNOVA1 909825VAINNOVA 910343NHIN4 912486CATH1 913345MI1 916781INNOVA1 918333JPIN1 918333JPIN2 918494IN31A 919731WMINOV 919784REP1 9202623100 925779INNOVA408 928779INNOVA1 931459CV1 936266CL1 940626DCH3100 941798CLAB2 951788INNOVA2 951788INNOVA3 951788INNOVA3 952993INNOVA5 954987CCL9 956389INN31 956698INN31 956994INN1 956994INN2 970350CL1 970945CL1 9734293100 973877LAB4 973971LAB3 BPINNOVA1 BPINNOVA2 BPINNOVA3R DR3100 ECXV1406B FHORLCL1 FHORLCL7 LVINOV4 MARTINSVILLE310 MCDCATH2 2575081 2601648 2610213 2625271 2638199 2652070 2656470 2661770 2680614 2681424 2682930 2686429 2698717 2699058 2713223 2713498 2713501 2713606 2716215 2724811 2725165 2727031 2728632 2729012 2729039 2730996 2731216 2731616 2732637 2739644 2741814 2742714 2745812 2745843 2745917 2749863 2750261 2751926 2752431 2753571 2753701 2754912 2754940 2754953 2754989 2755128 443481LCV 504447INNOVA2 580421V3100 609267IN3100 609597IN3100 610645LAB6 732776CATH2, and 909CH3100
  • 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 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane || 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