Events

Retiro De Equipo (Recall) de BABIX Holder for BuckyDiagnost Xray 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 Philips Medical Systems North America Co. Phillips.

¿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
    56707
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0021-2011
  • Fecha de inicio del evento
    2010-09-09
  • Fecha de publicación del evento
    2010-10-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-07-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94329
  • 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
    System, x-ray, stationary - Product Code KPR
  • Causa
    Potential of broken strands in the main steel cable supporting the accessory holder used with buckydiagnost and digitaldiagnost x-ray systems.
  • Acción
    Philips issued URGENT-Device Correction Notice letters dated September 9, 2010 to their consignees identifying the affected products and action to be taken by customers. The letter states that Babix holder used with Philips BuckyDiagnost and DigitalDiagnost X-Ray System - VS Wall Stand Risk of steel cable fracture in the support holder. The consignees are informed that there is a potential of broken strands at the main steel cable within the holder which cannot be recognized by the user. The firm will issue the Field Change Order (FCO) and the Service Engineer will replace the Babix holder. Consignees can call Philips Call Center at 800-722-9377, #5 (then follow prompts) and reference to FCO 70400038 for the BuckyDiagnost X-ray system and FCO 71200046 for the DigitalDiagnost X-ray system.

Device

BABIX Holder for BuckyDiagnost Xray system
  • Modelo / Serial
    Devices are identified as Site Numbers: 546607, 48682949, 554660, and 555738.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution in the states of CA, GA, and TN.
  • Descripción del producto
    The BABIX holder is an accessory used with the BuckyDiagnost X-ray system. It is used to hold the baby either in a secured or immobilized standing position in front of the X-ray detector during the examination.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Dirección del fabricante
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA