Events

Recall of Philips DigialDiagnost X-Ray System

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 DMC GmbH.

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
    13858
  • Event Initiated Date
    2012-11-29
  • 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
    With digitaldiagnost (didi) r 2.0.2 a mirrored "r in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. when such an image is mirrored back inside the pacs system, an unmirrored "r in a circle" appears in the lower left corner. this can be mistaken for a "right patient side" marker, although this can appear on the left patient side., philips previously notified owners of affected digitaldiagnost systems that software release 2.1.3 would be installed on their systems to modify the appearance of the mirror icon, as described below. however, software release 2.1.3 contained a defect that may result in the incorrect placement of the electronic marker (left/right) indicating the patient side if an image is rotated.
  • Action
    Software to be upgraded

Device

Philips DigialDiagnost X-Ray System

Manufacturer

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