Events

Recall of MobileDiagnost wDR (digital diagnostic X-ray imaging 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-01277-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-12-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01277-1
  • 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
    When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position on the resulting image. electronic patient side (left / right) markers on wrong image.
  • Action
    As an interim measure, Philips is advising users to manually rotate an image with the rotation tool and to use a L/R lead marker to mark the patient side permanently in the image instead of using the automatic L/R markers from the EPX-database. Philips will implement a software update to solve this issue.

Device

MobileDiagnost wDR (digital diagnostic X-ray imaging system)
  • Model / Serial
    MobileDiagnost wDR (digital diagnostic X-ray imaging system)All MobileDiagnost wDR except USARTG number: 187112
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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