Events

Rappel de Mobile Detector Holder Trolley (9890-010-88152) (used to support the transport and utilisation of a portable/mobile radiological imaging system)

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-2017-RN-01217-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-09-27
  • 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-2017-RN-01217-1
  • 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 has recently performed evaluations of the mobile detector holder and has identified a potential issue that may affect the performance of the equipment under certain conditions. if the lock mechanism of the movable clamp of the mobile detector holder is not adjusted properly or not secured, the portable detector can drop down when the moveable clamp is at the bottom (below of the detector) and additional force is applied. this may happen when the detector is rotated clockwise from landscape to portrait position.The wireless portable detector (wpd) is fixed in the mobile detector holder via a lock mechanism. the 4 countersunk screws, that are used to attach the lock mechanism, can become loose. if this happens and the mechanism fails, the detector may fall down when the holder is rotated 90° clockwise from landscape.
  • Action
    1. Users should read the notice and check the lock mechanism of the Mobile Detector Holder. The lock mechanism can be moved without pressing the actuator, the holder should not be rotated clockwise. a. Distribute the notice to all users of the device and complete the supplied response form and return it to. Philips via fax/email within three (3) business days. b. Philips will contact users to schedule a correction to the affected units.

Device

Mobile Detector Holder Trolley (9890-010-88152) (used to support the transport and utilisation of...
  • Modèle / numéro de série
    Mobile Detector Holder Trolley (9890-010-88152) (used to support the transport and utilisation of a portable/mobile radiological imaging system)ARTG Number: 293924
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA