Events

Retiro De Equipo (Recall) de Device Recall Digital Fluoroscopic Imaging System

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
    51193
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1195-2009
  • Fecha de inicio del evento
    2008-11-21
  • Fecha de publicación del evento
    2009-05-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-11-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79028
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Causa
    Ge healthcare has become aware of a potential image storage failure on innova 2121 iq/ 3131 iq cardiovascular imaging systems that may impact patient safety. this intermittent communication failure on the image storage chain may result in the following situations: record abort, record not available, fluorostore function not available, review not available, boot/reset failure. fluoroscopy imag.
  • Acción
    A GE Healthcare "Urgent Medical Device Correction" letter dated February 2, 2009 was sent to consignees via mail. The letter was directed to Hospital Administrator/Risk Manger, Managers of Radiology/Cardiology and Radiologists/Cardiologists addressing the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. Further questions should be addressed to GE Healthcare at 1-800-437-1171.

Device

Device Recall Digital Fluoroscopic Imaging System
  • Modelo / Serial
    Product Number: 2121-IQ; Serial Numbers: 410614CV2, 253627INNOVA5,  808547QCV4, IE1100VA03, 713794LAB11, 936WH2121, 3108252121A, 416480INNOVA2, 3108252121B, 215576INNOVA2, 617636IN2121, 304526INNOVABP, 853060201, 541743CL5, 4105502121, 202782LABA, 857307IN32121, YV0362, YV0369, 610526LAB3, 610954BP1, 612273INNOVA3, 410614CV1, 857307IN12121, 857307IN22121, 319272EP, YV0363, 904202WCL1, 4146492121, FHORLEP4, FHORLEP5, 206598UWBP, 316268BIPLANE and HSRINNOVA1 and  Product Number: 3131-IQ; Serial Numbers: 8184093131, 00440VAS04, 509474BIP, 561548BIP, 812238UNBPL, 615222BIH, 303425CL2, 516562INNOVA1, RO1095VA01, 6263973131, YV0462, YV0463, 853060198, 4144473131, BH1000VA01, 5135843131, 507385INN3131, 541382BP, YV0464, M4166990, YV0470, YV0166, 10307VAS01, 317338PV4, 309655FSP4A, YV0466, 773RES3131BP, 309655FSP2B, 713794LAB8, 630933INVLAB4, 518262BP1, 853060202, 00026VAS01, 410740CV, 834160004, 853060200, 301295EP, N4192939, COR373252, 2197383131, 718579INNOVABP, 83016900000000, 816932SL3131, 814877BP, 281637SL3131, 617525IN13131, FHORL3131, A5632421, FDO 0002769264, YV0471 and 834160005.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA including states of CA, CO, FL, HI, IA, IL, IN, KS, MD, MA, MN, MO, NY, OH, OR, PA, TN, TX, WA, WV, WI and VA and countries of the United Kingdom, Romania, Japan, Taiwan, Bahrain, France, Malaysia, India, Canada, Chile, Indonesia, Ireland and Italy.
  • Descripción del producto
    Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane systems with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures. The product is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and interventional cardiac angiography procedures. These systems can be operated in a mobile or fixed site environment.
  • 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