Events

Retiro De Equipo (Recall) de Manual Collimator Exchange system in use with an ADAC VERTEX Plus, CARDIO, SOLUS or VERTEX V60 imaging system(Nuclear Medicine Gamma Camera Systems)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia 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-2015-RN-00400-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-15
  • 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-2015-RN-00400-1
  • 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
    Philips healthcare received a report that during a manual collimator exchange procedure, when the operator was attempting to slide the collimator cassette from the collimator storage cabinet onto the collimator exchange carriage, the cassette did not align with the carriage top guide rollers and mechanical lock. the collimator and collimator cassette fell off the carriage resulting in the operator receiving a minor injury. this could result in serious injury to a person if it comes in direct contact with the operator. automatic collimator exchange system is not affected.
  • Acción
    Philips Healthcare is instructing their customer not to proceed with collimator exchange procedure, if a misalignment on the top and/or bottom of the guide rail between the cabinet and carriage can be visually detected Philips Healthcare service technician will fix the issue prior to the continued use of the system. UPDATE: Philips is advising their customer that they must ensure collimator alignment is inspected via regularly scheduled Preventive Maintenance at 3 month intervals. An updated procedure for inspecting collimator alignment has been provided. This action has been closed-out on 10/08/2016.

Device

Manual Collimator Exchange system in use with an ADAC VERTEX Plus, CARDIO, SOLUS or VERTEX V60 im...
  • Modelo / Serial
    Manual Collimator Exchange system in use with an ADAC VERTEX Plus, CARDIO, SOLUS or VERTEX V60 imaging system(Nuclear Medicine Gamma Camera Systems)ARTG number: 117642
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA