Events

Recall of Mobile Detector Holder for DigitalDiagnost System (Digital diagnostic x-ray System).

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2012-RN-01024-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2012-10-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01024-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    The wireless portable detector 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 degrees clockwise.
  • Action
    The user should control the lock mechanism of the Mobile Detector Holder. In case the lock mechanism can be moved without pressing the actuator, the holder should not be rotated Clockwise. Philips Healthcare will secure the 4 countersunk screws, which are used to attach the lock mechanism, with thread locker (e.g. LOCTITE 243).

Device

Mobile Detector Holder for DigitalDiagnost System (Digital diagnostic x-ray System).
  • Model / Serial
    Mobile Detector Holder for DigitalDiagnost System (Digital diagnostic x-ray System). Models: Single Detector, Dual Detector, Release 3System codes: 712020, 712022 & 712025ARTG Number: 117662
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA