Events

Retiro De Equipo (Recall) de Sirona Dac Universal Combination Steriliser

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Sirona Dental Systems 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-2016-RN-00771-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-20
  • 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-2016-RN-00771-1
  • 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
    Dac universal mkiii units may have been repaired using spare parts intended for mkii units. there is the possibility of 12mm screws being used as a replacement for the original 16mm screws in the lid holder assembly. in the case, where the incorrect screws are fitted the lid could possibly become unmounted from the unit during its operation. there is a risk that people standing nearby could be harmed if hit by a released lid.
  • Acción
    Sirona is advising users to discontinue use of the affected machines until a service technician has inspected and corrected the machine, where required. Users are reminded to continue to manually clean and lubricate the instruments using T1 spray. This action has been closed out on 15 June 2017.

Device

Sirona Dac Universal Combination Steriliser
  • Modelo / Serial
    Sirona Dac Universal Combination SteriliserSerial Number Range: 104000-199999, 202000-999999, B14000-B99999, B104000-B199999, B202000-B999999ARTG Number: 197032
  • Manufacturer
    Sirona Dental Systems Pty Ltd

Manufacturer

Sirona Dental Systems Pty Ltd