Retiro De Equipo (Recall) de Slide-in Plug Adaptor for Charger used with Haag Streit UK Perkins MkIII Tonometer Tonometer

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies Australia 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-2014-RN-00736-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-04
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    Haag streit has identified a potential issue with the slide-in adaptor plug for the perkins mkiii tonometer charger. an incident was reported to haag-streit where the use of the adaptor tripped a customer’s circuit breaker. upon investigation it was found the adaptor contained an electrical fault. this electrical fault has the potential to cause arcing within the adaptor, which poses a potential fire hazard. the risk when using the adaptor is most apparent if the adaptor is used in an un-fused circuit. the risk of harm and damage can be reduced if the unit is plugged into a conforming power outlet with a circuit breaker.
  • Acción
    Users are advised to isolate the affected Plug Adaptors from use. A DTA representative will contact users in regards to replacement of affected stock.

Device

  • Modelo / Serial
    Slide-in Plug Adaptor for Charger used with Haag Streit UK Perkins MkIII Tonometer Tonometer Product Code: CC-5806004Serial Numbers: 274, 275, 276, 731, 732, 733, 453, 490, 452, 360ARTG Number: 151673
  • Manufacturer

Manufacturer