Events

Retiro De Equipo (Recall) de Device Recall GE Healthcare, Innova 3100 and Innova 4100 systems

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 Healthcare, 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
    65022
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1616-2013
  • Fecha de inicio del evento
    2011-05-16
  • Fecha de publicación del evento
    2013-06-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117676
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Causa
    Ge healthcare reported a potential safety issue due to temporary loss of x-ray imaging modes during collimator auto-calibration which affects innova 3100 and innova 4100 systems.
  • Acción
    A Customer Letter was not originally sent. GE Healthcare has retrospectively re-assessed the reportability of the field action and has determined that the action should be reported to the FDA. GE Healthcare has already updated all of the affected Innova 3100 and Innova 4100 systems that were distributed. As an effectiveness check, they have tracked all service requests for the field action to completion. These service requests have recorded the repair of the affected units. Exceptions to completion of the service request have been recorded as well. Records of field action completion have been retained per their processes and procedures. If you have any questions, please call 262-548-2757. For questions regarding this recall call 262-513-4122.

Device

Device Recall GE Healthcare, Innova 3100 and Innova 4100 systems
  • Modelo / Serial
    SERIAL NUMBER 00000007C20103 0000010C2M0069 0000010C2M0181 0000010C2M0214 0000010C2M0259 0000010C2M0137 0000010C2M0159 0000010C2M0262 0000009C2M0084 0000010C2M0130 0000010C2M0218 0000010C2M0297 0000009C2M0108 0000010C2M0236 0000009C2M0167 0000010C2M0208 0000010C2M0295 0000000DUMMY01 00000009C20099 00000007C20141 00000595660BU2 0000010C2M0063 0000010C2M0083 0000009C2M0041 0000010C2M0180 0000010C2M0189 0000010C2M0174 00000593054BU0 00000007C20150 0000010C2M0027 0000010C2M0121 0000010C2M0229 0000010C2M0253 0000010C2M0122 0000010C2M0005 00000007C20173 0000009C2M0040 0000009C2M0077 0000010C2M0088 0000010C2M0097 0000010C2M0143 0000010C2M0192 0000010C2M0193 0000010C2M0204 0000010C2M0294 0000010C2M0269 0000010C2M0176 00000498682BU4
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution - USA including AZ, CA, CO, FL, ID, IL, ME, NV,NY, NC, OK, TN, UT, and WI; and Internationally to Canada, Chile, France, Germany, Italy, Japan, Korea, Norway and Spain.
  • Descripción del producto
    GE Healthcare, Innova 3100 and Innova 4100 systems. || The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

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