Events

Recall of Brilliance iCT and Brilliance iCT SP with software versions 4.1.0.xxxxx, or 4.1.1.xxxxx, or 4.1.2.xxxxx

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-00068-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-01-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00068-1
  • 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 has identified a software defect that may result in the scanner updating the planned scan length to be longer than the user intended. this may happen if:1. the exam is planned with low pitch and rotation time values, for example, 0.3 pitch and 0.27 rotation time, and2. the plan scan length is increased or lengthened on the surview/scout, and3. the system displays a pop-up message that the current pitch, rotation time, and planned scan length are incompatible and suggests a new pitch and rotation time. 4. if the user accepts the suggested pitch and rotation time changes, the system adjusts the plan to the maximum allowed scan length, which will plan the study beyond the original intended length.
  • Action
    Philips is providing instruction to assist identify if a system is affected and advising end users to ensure that the scan length is verified prior to initiating the scan. A Philips Field Service Engineer will contact affected customers to arrange for the software to be updated. This action has been closed-out on 19/07/2016.

Device

Brilliance iCT and Brilliance iCT SP with software versions 4.1.0.xxxxx, or 4.1.1.xxxxx, or 4.1.2...
  • Model / Serial
    Brilliance iCT and Brilliance iCT SP with software versions 4.1.0.xxxxx, or 4.1.1.xxxxx, or 4.1.2.xxxxxARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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