Events

Recall of MX 16-slice CT x-ray systems with software version v1.1.4.21426.

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-00616-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-05-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00616-1
  • 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 following issues have been found in mx 16-slice systems.1) during the filming operation, the clipboard used for copying and pasting images is not cleared between patients. if the operator fails to copy the current patient’s images before pasting, a previous patient’s images may be present in the clipboard and be copied onto the film of the current patient. 2) during the bolus tracking scan, if the auto voice in tracker scan is enabled, the tracker scan will be aborted unexpectedly and the diagnostic scan after the tracker scan needs to be manually started.3) if the scan protocol with sas (spiral auto start) function is selected to plan the scan, the sas option may not be displayed on the contrast tab of the scan protocol parameter area or the sas option is displayed but not enabled as pre-configured in the protocol. this issue only occurs on the first helical scan after system startup that applies sas function.There have been no reports of injuries.
  • Action
    Philips is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent correction. This action has been closed-out on 02/03/2017.

Device

MX 16-slice CT x-ray systems with software version v1.1.4.21426.

Manufacturer

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