Events

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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00400-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-05-15
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00400-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
    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
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA