Events

Recall of Philips Brilliance 64, Ingenuity Core128 and Ingenuity CT with software version 4.1.6

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-2017-RN-01387-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01387-1
  • 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
    Philips have identified multiple issues with the philips brilliance 64 / ingenuity family running software version 4.1.6issue 1: cardiac signal not found in workflow issueissue 2: scan may start at the top of the head, which may not be where the operator is expecting the scan to startissue 3: pulmo gates on cardiac workflow issueissue 4: in the plan viewer if the start position is modified the total length of the acquisition will changes as well.Issue 5: image volumes are not found in patient directory when thin images are included in one of the multiple results issue 6: application may fail when modifying the results plan box during 3d calcium score issue 7: tube too hot issue 8: memory overflow issueissue 9: while the reconstruction is in progress disconnecting the recon box (cirs) may not give error messageissue 10: issue with the generator monitor state machine in rhost code issuethere have been no injuries reported as a result of these issues.
  • Action
    Philips is providing users with work around instructions to follow as an interim measure. Philips will be performing a software update as a permanent correction.

Device

Philips Brilliance 64, Ingenuity Core128 and Ingenuity CT with software version 4.1.6
  • Model / Serial
    Philips Brilliance 64, Ingenuity Core128 and Ingenuity CT with software version 4.1.6ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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