Events

Recall of MobileDiagnost wDR 2, all software versions affected (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-2016-RN-00595-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-05-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00595-1
  • 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
    During recent evaluations of the philips mobilediagnost wdr 2, philips has identified a potential issue that could result in unnecessary radiation exposure to the patient under certain conditions. 1. the system may sporadically apply the default x-ray exposure parameters for an adult (patient type: “normal”), even though the patient type “newborn” was selected and is displayed in the generator control area of the eleva user interface.2. under certain conditions, the detector might not be ready for examination. released x-ray might lead to an image with artefacts and a retake is required. while the attachment process is running, the detector might be too short in front of the ir (infrared) sensor and the problem of the washed out images can appear if an exposure is taken right after that.
  • Action
    Philips is providing work around instructions for users to follow as an interim measure. A software upgrade will be implemented as a permanent correction.

Device

MobileDiagnost wDR 2, all software versions affected (diagnostic x-ray system)
  • Model / Serial
    MobileDiagnost wDR 2, all software versions affected (diagnostic x-ray system)All systems affectedARTG Number: 187112
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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