Events

Retiro De Equipo (Recall) de C- Series lifts Manufactured between April 25, 2017 and June 12, 2017

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

¿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-2017-RN-01450-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-12-13
  • 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-2017-RN-01450-1
  • 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
    During internal cycle testing of c-series lifts handicare has found that the c-series lift strap for lifts manufactured between april 25, 2017 and june 12, 2017 may wear prematurely at max load (625 lbs). we have identified the root cause as a supplied component that was not to specification. if the strap wears during use there is a potential risk for the person being supported by the lift to drop.This issue was identified internally. to date, chs is not aware of any c-series lift strap incidence related to this issue.
  • Acción
    CHS Healthcare will be in contact with affected customers to arrange removal of the current hoist and reinstall of a new unit.

Device

C- Series lifts Manufactured between April 25, 2017 and June 12, 2017
  • Modelo / Serial
    C- Series liftsManufactured between April 25, 2017 and June 12, 2017ARTG 292642
  • Manufacturer
    CHS Healthcare Pty Ltd

Manufacturer

CHS Healthcare Pty Ltd