Events

Retiro De Equipo (Recall) de W & H Foot Control - S-N1/S-N2

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por A-DEC Australia.

¿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
    RC-2018-RN-00006-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-01-16
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00006-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    A-dec has been made aware of a potential malfunction with certain w&h; foot controls. the foot control might not switch back to zero position when the pedal is released. consequently, the motor keeps rotating. if this happens during automatic thread cutting or automatic screwing-in of implants, it can, in the worst case, lead to a serious injury of the patient. so far, no incident has been reported.
  • Acción
    A-Dec will contact affected customers to arrange replacement foot controls to be provided. In the interim, the affected products must not be used for thread cutting and screwing in of implants. These operations have to be conducted manually.

Device

W & H Foot Control - S-N1/S-N2
  • Modelo / Serial
    W & H Foot Control - S-N1/S-N2Multiple Affected Serial NumbersARTG 125363 (ADEC AUSTRALIA - Implantmed (various models) - Drill/saw system, dental)
  • Manufacturer
    A-DEC Australia

Manufacturer

A-DEC Australia
  • Source
    DHTGA