Events

Recall of Philips Ingenuity Core128 with Software Version 3.5.5 (whole body Computed Tomograph (CT) x-ray system)

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-2014-RN-00417-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-04-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00417-1
  • 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
    An issue has been found with the ingenuity core128 system with software version 3.5.5. if additional acquisitions/scans are requested prior to completion of the current reconstructions, not all planned images from the current reconstruction are displayed to the user. users may not be aware the information is not lost, as the raw data can be reconstructed off-line displaying all requested reconstructions. if a rescan is required, there is potential for unnecessary radiation.
  • Action
    Philips is requesting customers to verify that all planned image reconstructions are completed and to perform off-line reconstructions, if expected images are missing. Philips will be installing a software update to correct the issue. This action has been closed-out on 01/02/2016.

Device

Philips Ingenuity Core128 with Software Version 3.5.5 (whole body Computed Tomograph (CT) x-ray s...
  • Model / Serial
    Philips Ingenuity Core128 with Software Version 3.5.5 (whole body Computed Tomograph (CT) x-ray system)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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