Events

Retiro De Equipo (Recall) de C-Series LiftsPrism Medical/Waverly Glen FSN-0016A

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Rehab Assist 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-01442-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-12-11
  • 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-01442-1
  • 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
    Rehab assist has been made aware by prism medical usa (a division of handicare), that during an internal cycle testing of c-series lifts it is determined that the c-series lift straps for lifts manufactured between april 25, 2017 and june 12, 2017 may wear prematurely at max load (625lbs). the root cause has been identified 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.There have been no known incidents of hoists in use, only in internal routine cyclical testing.
  • Acción
    Rehab Assist will be in contact with affected customers to arrange for replacement of affected devices. This recall action only relates to the serial numbers stated for this Sponsor.

Device

C-Series LiftsPrism Medical/Waverly Glen FSN-0016A
  • Modelo / Serial
    C-Series LiftsPrism Medical/Waverly Glen FSN-0016AItem Numbers: 1-323100, 1-323211, 1-323149Model 323100 C450 Manual Traverse Serial Numbers C4M0018959 and C4M0018962Model 323211 C450 Manual Traverse Rev A Serial Number C4M0018956Model 323149 C450 Power Traverse Serial Number C4P0009806ARTG Number: 169639
  • Manufacturer
    Rehab Assist Pty Ltd

Manufacturer

Rehab Assist Pty Ltd