Events

Recall of Philips Ingenuity CT, Ingenuity Core and Ingenuity Core 128

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
    17514
  • Event Initiated Date
    2014-10-10
  • 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
    This field safety notice to inform customers that software was upgraded from version 3.X to version 4.0.0 / 4.0.1, the protocol conversion can result in incorrect scan parameters, which in turn can result in delayed images, when using the cct option. report that first image was marked as "last shot" rather than the actual "last shot" acquired. after the clinician pressed the pedal for first exposure, images were displayed as the "last shot". subsequent pedal presses did not result in immediate image reconstruction and the first image remained on the screen labeled as the "last shot". eventually all images appeared., the problem is caused by incorrect slice increment settings in the user set for cct protocol resulting from the protocol to exam card conversion during the software upgrade from v3.X to v4.0.0 / v4.0.1.
  • Action
    Manufacturer to issue advice regarding use

Device

Philips Ingenuity CT, Ingenuity Core and Ingenuity Core 128

Manufacturer

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