Events

Recall of Philips MX 16-slice Computer tomography x-ray system (software upgrade from v2.0.0.21479 to v2.0.0.21480)

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-2015-RN-01082-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-11-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01082-1
  • 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
    In 2d and filming function, when image is zoomed and saved as derived dicom format, the measurement on new created image is incorrect. this issue only occurs on mx16 systems with software version v2.0.0.21479, including mx16 evo2 systems and mx 16 systems upgraded to mx16 evo2 using the mx16 idose4 upgrade kit.Image with incorrect measurement value may be used to guide clinical procedures where measurement is critical. this may lead to misdiagnosis.
  • Action
    An initial workaround is provided for users in the Customer Letter. Philips will release Field Change Order (FCO) 72800646 to upgrade the software free of change. A Philips Field Engineer will contact users to schedule this correction. This action has been closed-out on 31/08/2016.

Device

Philips MX 16-slice Computer tomography x-ray system (software upgrade from v2.0.0.21479 to v2.0....
  • Model / Serial
    Philips MX 16-slice Computer tomography x-ray system (software upgrade from v2.0.0.21479 to v2.0.0.21480)Affected Products: Philips MX 16-slice CT Systems with software version v2.0.0.21479 ARTG Number: 158775
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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