Events

Recall of Philips Brilliance 64 and Ingenuity CT/Core/Core128 with software versions 4.1.6.XX030 or 4.1.6.XX032

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-01528-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01528-1
  • 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
    A complaint was received by philips indicating that the non-gated bolus tracking clinical scan failed to initialise with the system displaying the error message:“a problem has occurred; please retry. if the problem persists contact service.” this resulted in the study being cancelled with a loss of bolus. if this were to re-occur, it may necessitate a rescan.
  • Action
    Philips Healthcare will be installing a software update to correct the issue. A Philips Field Service Engineer will contact affected customers to schedule the software update installation at their site. In the interim, customers are advised that when failure occurs the users may : 1. Continue initiating the diagnostic scan manually. 2. Repeat the bolus tracker scan Customers are also advised to use one of the workaround options provided in the customer letter to prevent the failure of non-gated Bolus Tracking clinical scans with dose modulation.

Device

Philips Brilliance 64 and Ingenuity CT/Core/Core128 with software versions 4.1.6.XX030 or 4.1.6.X...
  • Model / Serial
    Philips Brilliance 64 and Ingenuity CT/Core/Core128 with software versions 4.1.6.XX030 or 4.1.6.XX032ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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