Events

Retiro De Equipo (Recall) de Device Recall Innova 3100/3100IQ

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por GE Medical Systems, LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    49539
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0474-2009
  • Fecha de inicio del evento
    2008-01-30
  • Fecha de publicación del evento
    2009-01-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-03-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73762
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Image-intensified fluoroscopic x-ray system - Product Code MQB
  • Causa
    Software error, computer: ge healthcare has became aware of an issue with error management affecting the innova 2100, 3100/3100 iq & 4100/4100iq. it was reported that when the foot switch was pressed, the live monitor screen was blank and it looked like there were no x-rays being emitted. but the message "acquisition in progress" was displayed on the dl monitor, even after the foot switch was r.
  • Acción
    Consignees sent a "GE Urgent Medical Device Correction" letter dated February 28, 2008. The letter was addressed to Hospital Administrators/Hospital Risk Management Department/Managers of Radiology-Cardiology/ Radiologists-Cardiologists. The letter described the affected products, safety Issue, short term recommendations, long term solution and contact Information. The first batch of letters was received by customers on 5/28/08. For further information, please contact GE Healthcare at 262-544-3894

Device

Device Recall Innova 3100/3100IQ
  • Modelo / Serial
    215576INNOVA1 760242CATH1 404686CRI3 281420LAB23100 541382CV3 205783BCL5 2035763100 508941IN1 843797TCL2 361980INNOVA2 214590PH3100 303629CL4 303629EP 3027443100 7018573100 303788CL2 239939CLA 850862IN3100 352333CATH1 352333CATH2 8184093100 919731WMINOV 305364P3100 205877CCL1 281440CL3 208227CATH2 2014183100 7028533100 865693CCL1 609757IN3100 6619483100 219326IN31 7022333100 816969LSCATH 209334LINNOVA1 310319SM3100 502587LAB1 219877IN31 9734293100 215335INNOVA1 239436CATH3 239513CRLAB1 8053703100 615222H 812858GWLAB1 812858GWLAB2 8014793100 270688INN 65049331 850747BR3100 6106483100 8508573100 850469BCV1 207662CL4 207879CL131 951788INNOVA3 951788INNOVA2 541677MINNOVA1 5033703100 253968INNOVA 254742KDCL1 662377CV4 412437INNOVA 9202623100 303425CL4 2197573100 0002595303 228818VASC 316651INNOVA31 316962WCVC1 316962WCVC2 325428CATH1 325428CATH3 336832MCPV 360456XCL3 361857CATH1 405272SCL2 405372S3100 405604D3100 405840OIC3100 406447VAIN3 406543IN3 413582C3100 414447CL1 414647CL1 414649CL3 414649CL4 414805INNOVA1 415925INV1 417885JCL7 417885JCL8 423495MCL6 423844CCL1 478274CTH1 502852INNOVA 510797INV8 512901NI3100 516562INNOVA8 516562INNOVA9 516663INNOVA1A 530244XC106 561548CL4 570476INNOVA31 573458CL1 573632CRC2 6012883100CV2 603421PCL 610595CL1 610770INNOVA31 610983INNOVA1 616392INNOVA 617732IN9 618241GSI3100 620225INNOVA31 631968INNOVA2 631968INNOVA3 662377CV2 671GMHAINVA 708WESTSUB3100 713359INC 713948INA 717782INNOVA31A 718245UNITY 718470INNOVA2 718780CATH2 732776CATH6 770991CL1 772LWCL1 775982CATH2 781340IN2 803255CL1 804285CATH1 814676C1 815344CARDIAC3 815756KCHSPEC 816478MC1 816861KCVAI1 816943STJIC1 816985NKCI 847362CONCATH4 856596IN3100 864255SFCL3 901516R3 903UT3100 904276CTH1 909464IN3 909825VAINNOVA 910343NHIN4 913345MI1 940626DCH3100 954987CCL9 956698INN31 970350CL1 970945CL1 973877LAB4 ECXV1406B FHORLCL7 580548B3100 941798CLAB2 760323DRINNOVA 718270INNOVA1 603580ECL1 410740CV MARTINSVILLE310 480728LAB2 865481CCL2 405610NW3100 8157413100 251633PROV 907562CATH1 919784REP1 601883CL1 650369SV3 610954INNOVA1 760242CATH2 314768SMCL1A 2035763100A 402559UCB 561694IN1 2036883100 201996LAB1 205877CCL2 207351YCL1 251435ICV6 281420LAB1 314525STACL2 334418CL 412623LAB2 479441SP3100 480821IN2 508856IN2 541MWHINNOVA 573882UMC1 610447CL1 610526LAB1 610526LAB2 610891CL1 617789IN1 631376EP 704384CATH2 706481CCL 706774CCL4 706774CCL5 713776M3100 717782INNOVA31 803256PCL1 812450CATH1 815226INN2 863687CL31 916781INNOVA1 918494IN31A 952993INNOVA5 BPINNOVA1 845365V19 918333JPIN1 909788INNOVA1 516663INNOVA2 2652143 8185023100 0002686429X 312STMNAZ3100 630312B31  717782INNOVA31B 727725CATH2  785354S3100  918333JPIN2  378INV31 0910064009 0910163012 0910163013 0910163015 910064007 910064008 910162006 910162008 910163006 910163007 910163009 BA4080VA01 140024RX09 BG4549VA02 2573329 2667313 2676587 BE5003VA02 082416040018 082416140004 082416290001 082416140003 082416130018 082416080001 082416010006 082416020004 082416020005 082416030006 082416040015 082416040019 082416100013 082416110002 082416110003 082416120010 082416140002 082416150001 082416160008 082416160009 082416160013 082416180004 082416190004 082416190001 082416190002 082416190003 082416210006 082416210008 082416220008 082416270002 082416300001 082416310003 082416310006 082449100050 082416160011 082416170002 82416030003 82416030008 82416030010 82416100006 82416100010 82416100019 82416120007 82416120011 82416130015 82416160003 82416160006 82416210003 82416210004 82416310007 082416220009 82416130017 82416030009 82416120012 82416180005 82416310008 2625365INNOVA 2645993INNOVA CS1006VA03 HC4348XR01 0002655786 MPX82206 FPG86403 FPG93008 DPM32143 DPN88402 FPA99414 FI1064VA01 M2030709 M4163030 M4166988 M5480755 M6083613 A6017504 M2848425 M2970614 M4016034 M40480151 A9190149 M40480167 00203VAS01 01367VAS02 GE1005VA01 HU1099VA04 A5127281 A5112597 A5162256 A5333035 A5812244 B5274834 B5332001 B5810907 A5125119 JO1000VA01 YV0162 YV0048 YV0163 XF0250 YV0033 YV0034 YV0035 YV0038 YV0039 YV0040 YV0042 YV0043 YV0044 YV0045 YV0046 YV0047 YV0049 YV0050 YV0051 YV0023 YV0024 YV0025 YV0027 YV0028 YV0029 YV0030 YV0031 YV0032 YV0037 0850060719 0850060724 0850060726 0850060727 0850060728 KW1055VA01 52XVINN2565367 818INNOVAHM2  477XVIN2553211 0834160003 NO1005VA05 0920169007 2048000INNOVA 2664627INNOVA 2685467INNOVA PL1082VA01 600098VA01 RU1482VA02 RU1475VA01 RU1142VA01 RU2581VA01 SA1010VA02 01012VAS01 41018VAS01 58002VAS01 60001VAS01 34268VAS01 0853060194, and  388567772VASMET
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA including states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL IN, KS, KY, LA, ME, MD, MA, MI,MN, MS,MO, MT, NE, NV, NH, NJ, NM, NY,NC, ND, OH, OK OR, PA, RI, SC, SD, TN, TX UT,VT, VA, WA,WV, and WI; the United States territory of Puerto Rico; and countries of ALGERIA, AUSTRALIA, BELARUS, BELGIUM, BOSNIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ,FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN,KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND,NORWAY, PANAMA, POLAND, PORTUGAL RUSSIAN FEDERATION SAUDI AR ARABIA, SINGAPORE, SLOVAKIA, SPAIN, SUDAN, SWEDEN SWITZERLAND, SYRIA, TAIWAN, TURKEY UNITED KINGDOM, and VENEZUELA.
  • Descripción del producto
    GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, 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) The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

GE Medical Systems, LLC
  • Dirección del fabricante
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA