Events

Recall of Philips DynaCAD 3

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by iCAD Inc.

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
    22643
  • Event Initiated Date
    2018-02-21
  • 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
    The manufacturer has become aware of a problem which causes images processed with pharmacokinetic (pk) results and/or dynacad calculated apparent diffusion coefficient (adc) maps have incorrect color overlay results as well as in the case of the adc images, incorrect values reported. the defect exists on any dynacad client system running software versions 3.4 or 3.5.
  • Action
    Software to be upgraded

Device

Philips DynaCAD 3
  • Model / Serial
    Model: DynaCAD 3.4 and 3.5, Affected:
  • Manufacturer
    iCAD Inc

Manufacturer

iCAD Inc
  • Manufacturer Parent Company (2017)
    Icad Inc.
  • Source
    NZMMDSA