Events

Retiro De Equipo (Recall) de Device Recall Getinge

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 Getinge USA Inc.

¿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
    61974
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2079-2012
  • Fecha de inicio del evento
    2012-05-25
  • Fecha de publicación del evento
    2012-07-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-05-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109621
  • 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
    Disinfector, medical devices - Product Code MEC
  • Causa
    Getinge disinfection ab is voluntarily correcting washer disinfectors, getinge electrically heated 9100-series manufactured between 2009-05-04 through 09-26-2011. this action is based on a report from the ground fault breaker manufacturer of a production error.
  • Acción
    Getinge USA issued a Device Correction Notice dated June 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to perform a trip test to determine if they have a functioning ground fault breaker. Customers will be contacted by a Getinge representative to schedule an appointment to exchange the earth fault breaker. Customers were provided a Customer Response Form to complete and fax back to 585-272-5033. For questions customers should call 800-475-9040, ext. 5270. For questions regarding this recall call 585-475-1400.

Device

Device Recall Getinge
  • Modelo / Serial
    Serial numbers: W50024258; W50024259; W50026573; W50025790; W50017381; W50020296; W50028138; W50020952
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including Maryland, Indiana, New Mexico, Massachuesetts, Texas, Kansas and the country of Canada
  • Descripción del producto
    Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and temperature stable Hospital case carts, sterilization containers, material handling carts, stands and utensils. --- Model numbers Getinge 9120, 9122, 9125, and 9128
  • Manufacturer
    Getinge USA Inc

Manufacturer

Getinge USA Inc
  • Dirección del fabricante
    Getinge USA Inc, 1777 E Henrietta Rd, Rochester NY 14623-3133
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA