Events

Recall of Philips Ingenuity Core (728321)

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-2018-RN-00312-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-04-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00312-1
  • 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 systems that may have been infected with the "wannacry" ransomware virus before installation. the virus may encrypt files in a way that:- prevents system access; or - a patient undergoing a scan or recently scanned whose results have not been reviewed may require a ct rescan; or- during a biopsy the system may be slowed such that the operator is unable to visualise the advancement of a biopsy needle in real timeto date, there have been no reports of patient harm as a result of this issue.
  • Action
    Philips are advising that they will be contacting users to arrange an appointment for a Field Service Engineer to correct the software on any potentially impacted systems

Device

Philips Ingenuity Core (728321)
  • Model / Serial
    Philips Ingenuity Core (728321)Serial Numbers: 333166, 333170, 333171, 333173-333181, 333184 ARTG Number: 98868(Philips Electronics Australia - X-ray system, diagnostic, computed tomography, full-body)
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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