Events

Recall of Philips Brilliance 64 and Ingenuity CT/Core/Core 128 CT Systems

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Philips Medical Systems (USA).

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
    20197
  • Event Initiated Date
    2016-05-25
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Reason
    1.Though internal testing the image orientation labels( l/ra/p) are not displayed during active scanning when switched from overview layout for volume interventional procedures., 2.Artifacts in the brain scans could be interpreted as finding hypo dense at bone brain interface while scanning using high resolution scan mode., 3. software issues found in the field and through internal testing were indentified on ict and ingenuity/ brilliance 64 with software v4.1.3 and 4.1.4., 4. varian rpm drive is not mapping in ct user profile after logout/login.
  • Action
    Software to be upgraded

Device

Philips Brilliance 64 and Ingenuity CT/Core/Core 128 CT Systems
  • Model / Serial
    Model: , Affected: , Software version: CT systems running software V4.1.3, 4.1.4, or 4.1.5
  • Manufacturer
    Philips Medical Systems (USA)

Manufacturer

Philips Medical Systems (USA)
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NZMMDSA