Retiro De Equipo (Recall) de Device Recall GE Advantx Legacy

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.

¿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
    49467
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1611-2008
  • Fecha de inicio del evento
    2008-01-02
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2011-12-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Table - Product Code IXR
  • Causa
    Ge healthcare was notified that 2 recently installed precision 500d systems were not in compliance with portions of the performance standard for diagnostic x-ray equipment. x-ray production was possible from the fluoroscopic x-ray tube when the primary protective barrier was not in position to intercept the x-ray beam. users are recommended to follow good clinical standards to ensure the image i.
  • Acción
    A Product Safety Notification letter, dated 01/09/2008 was sent to affected customers. This letter described the safety issue, affected product and safety instructions. A GE Field Engineer will schedule a field visit to affected customers to inspect and replace the park latch switch as needed.

Device

  • Modelo / Serial
    serial numbers: 000000000BH563, 00000004777GP9, 00000005003GP9, 00000014648GP0, 00000046998VP1, 00000048828VP8, 00000054168VP0, 00000054198VP7, 00000062777ES8, 00000062779ES4, 00000062797ES6, 00000062797VP6, 00000062813VP1, 00000062839ES6, 00000065436VP8, 00000066102DP5, 00000066138DP9, 00000076156MA9, 00000077242DP6, 00000077245DP9, 00000077246DP7, 00000077348MA1, 00000080468MA2, 00000084227VP8, 00000095705VP0, 00000097498WK1, 000000T7113MA8, 00000419764BU6, 00000431324BU3, 00000491331WK5, 00000493021WK0, 00000493022WK8, 00000494787WK5, 00000495471WK5, 00000495922WK7, 00000495960WK7, 00000498299WK7, 00000498516WK4, 00000498844WK0, 00000499720WK1, 00000499789WK6, 00000499936WK3, 00000500252WK2, 00000500371WK0, 00000500420WK5, 00000500452WK8, 00000500631WK7, 00000500800WK8, 00000500961WK8, 00000501080WK6, 00000501165WK5, 00000501317WK2, 00000501405WK5, 00000501497WK2, 00000501624WK1, 00000501678WK7, 00000501690WK2, 00000501845WK2, 00000502382WK5, 00000502469WK0, 00000502656WK2, 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  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, Washington D.C. and Puerto Rico and OUS to include: ARGENTINA, AUSTRALIA, BRAZIL, CANADA, CHILE, DOMINICAN REPUBLIC, EGYPT, GERMANY, HONDURAS, INDIA, INDONESIA, IRELAND, JAMAICA, KOREA, KUWAIT, MALAYSIA, MEXICO, NETHERLANDS, PANAMA, RUSSIAN FEDERATION, SAUDIA ARABIA, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM,
  • Descripción del producto
    Advantx Legacy Radiographic and Fluoroscopic systems, model 2102424, 2118104, 2157009, 2183000, 2206038, 2206048, 2206056, 2224559, 2258627, 2268730, 2330340, 2333974, 2118104-2, 2118104-3, 2118104-4, 2118104-5, 2118104-6, 2118104-7, 2118104-8, 2139574-2, 2147592-13, 2171204-2, 46-262751G6, 46-262751G7, 46-262751G8, 46-275382G58, and 46-302056G1. GE Medical Systems - Americas: Milwaukee, USA. The device is used to perform fluoroscopic examination of human anatomy.
  • Manufacturer

Manufacturer

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