Events

Retiro De Equipo (Recall) de Device Recall GE Healthcare Innova

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 General Electric Med 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
    37775
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0914-2007
  • Fecha de inicio del evento
    2007-02-05
  • Fecha de publicación del evento
    2007-06-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51505
  • 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
    Digital Fluoroscopic Imaging - Product Code MQB
  • Causa
    Unintended gantry movements : ge healthcare has recently become aware of accidental, operated-initiated activation of gantry movements associated with the new, metallic smart box controller that may impact patient or staff safely.
  • Acción
    Consignees were contacted via a letter "Urgent: Safety Notice" dated 2/5/07. The letter described the safety issue, affected product, safety instructions and product correction contact information. -This is the short-term fix, GE is working on a correction that will be installed at each site as the long term correction

Device

Device Recall GE Healthcare Innova
  • Modelo / Serial
    65049331 2035763100 3027443100 5033703100 6106483100 6619483100 7022333100 7028533100 8014793100 8157413100 9734293100 201996LAB1 207351YCL1 207662CL4 208227CATH2 214590PH3100 219326IN31 239513CRLAB1 239939CLA 251633PROV 281420LAB23100 303425CL4 305364P3100 316651INNOVA31 352333CATH1 352333CATH2 361857CATH1 361980INNOVA2 405272SCL2 406543IN3 413582C3100 414649CL3 414649CL4 415925INV1 423844CCL1 479441SP3100 480728LAB2 480821IN2 502587LAB1 508856IN2 512901NI3100 516562INNOVA8 516562INNOVA9 530244XC106 561548CL4 570476INNOVA31 573632CRC2 573882UMC1 610447CL1 610595CL1 610891CL1 616392INNOVA 617732IN9 618241GSI3100 708WESTSUB3100 717782INNOVA31A 718470INNOVA2 760242CATH1 775982CATH2 781340IN2 812450CATH1 812858GWLAB1 812858GWLAB2 814676C1 816478MC1 816943STJIC1 816985NKCI 847362CONCATH4 864255SFCL3 865481CCL2 870864LAB2 901516R3 903UT3100 904276CTH1 907562CATH1 909464IN3 909825VAINNOVA 913345MI1 916781INNOVA1 916781INNOVA1 918494IN31A 940626DCH3100 954987CCL9 970350CL1 970945CL1 405604D3100 405840OIC3100 412623LAB2 414647CL1 541MWHINNOVA 617789IN1 671GMHAINVA 770991CL1 41018VAS01 600098VA01 A5112597 A5125119 A5127281 A5162256 A5333035 B5274834 CS1006VA03 DPM32143 FI1064VA01 FPG86403 FPG93008 GE1005VA01 JO1000VA01 M4016034 M40480151 M4163030 M5480755 NO1005VA05 RU1142VA01 SA1010VA02 dpn88402 850060724 910064007 910162006 910163006 910163009 910163012 910163015 082416010006 082416020004 082416030003 082416040015 082416040018 082416040019 082416080001 082416100006 082416100013 082416110002 082416120007 082416120010 082416130015 082416130017 082416140002 082416150001 082416160003 082416160008 082416160009 082416190001 082416190003 082416190004 082416210003 082416210004 082416210006 082416210008 082416220008 082416220009 082416270002 082416300001 082416310003 082416310006 082449120007 0910064009X 834160003 910064008 920169007 YV0034 YV0043 YV0045 YV0046 YV0047
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Class II Recall - Worldwide Distribution --- USA including states of WV, WI, WA, VA, UT, TX, TN, SD, SC, PA, OR, OK,OH, NY, NV, NJ, NE, NC, MT, MO, MN, MI, ME, MD, MA, LA, KY, KS, IN, IL, ID, HI, GU, GA, FL, DE, CT, CO, CA, AZ, AL, AK and countries of UNITED KINGDOM, TURKEY, SYRIA, SWITZERLAND, SWEDEN, SPAIN, SAUDI ARABIA, RUSSIA, POLAND, NORWAY, NEW ZEALAND, THE NETHERLANDS, MOROCCO, MALAYSIA, KOREA, JORDAN, JAPAN, ITALY, ISREAL, IRELAND, INDIA, HUNGARY, GREECE, GERMANY, FRANCE, FINLAND , DENMARK, CZECH REPUBLIC, CHINA, CANADA, BELGIUM, AUSTRALIA, and ALGERIA.
  • Descripción del producto
    GE Healthcare Innova 3100/3100 IQ Digital Fluoroscopic Imaging system ( Cardiovascular Imaging System).
  • Manufacturer
    General Electric Med Systems LLC

Manufacturer

General Electric Med Systems LLC
  • Dirección del fabricante
    General Electric Med Systems LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Source
    USFDA