Events

Recall of Invivo DynaCAD Breast and Prostate with software versions 3.4 and 3.5

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-00163-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00163-1
  • 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
    A problem was uncovered which causes images processed with pharmacokinetic (pk) results and/or dynacad calculated apparent diffusion coefficient (adc) maps have incorrect colour 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
    Philips is advising users to discontinue use of the Ktrans, Kep, and iAUGC colormaps when assessing studies from a remotely connected DynaCAD client computer. It is further advised that users refrain from using the colormaps and values derived from ADC maps calculated by DynaCAD. ADC maps originating natively from the MRI system should be used as an alternative as these values are unaffected. Philips will provide a v4.0 software update for the affected software versions as a permanent correction.

Device

Invivo DynaCAD Breast and Prostate with software versions 3.4 and 3.5
  • Model / Serial
    Invivo DynaCAD Breast and Prostate with software versions 3.4 and 3.5Multiple serial numbers affectedARTG Number: 230620
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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