Events

Retiro De Equipo (Recall) de Device Recall CSeries Carry Bar

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 Prism Medical Services USA.

¿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
    65193
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1578-2013
  • Fecha de inicio del evento
    2013-01-27
  • Fecha de publicación del evento
    2013-06-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118206
  • 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
    Lift, patient, ac-powered - Product Code FNG
  • Causa
    The firm replaced the recalled carry bar with a plastic insert with a carry bar with a metal insert due to improper installation of the recalled carry bars.
  • Acción
    The firm, Prism Medical, sent a letter dated January 27, 2013 to is customers.The letter described the product, problem and actions to be taken. The customers were instructed to perform an immediate safety check checking that both the pin and the plug have been inserted into the carry bar as outlined in the attached User Instruction guide. Prism offered to replace the recalled product with a different product with greater functionality. If you have any questions, contact VP-Global Product Development at 416-726-3107.

Device

Device Recall CSeries Carry Bar
  • Modelo / Serial
    model number 360755
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (nationwide) and country of: Canada.
  • Descripción del producto
    Prism Medical C-Series Carry Bar, Class I, model number 360755. || The intended use is a carry bar attached to a C-450 or C-625 ceiling lift used to lift, transfer or position clients.
  • Manufacturer
    Prism Medical Services USA

Manufacturer

Prism Medical Services USA
  • Dirección del fabricante
    Prism Medical Services USA, 45 Progress Pkwy, Maryland Heights MO 63043-3701
  • Source
    USFDA