Events

Recall of Philips Allura Xper FD and Allura Clarity x-ray 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 Nederland BV.

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
    19424
  • Event Initiated Date
    2015-11-23
  • 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
    In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound, as is required in 21cfr1020.32 (h)(2)(ii) and iec 60601-2-54, clause 203.6.2.1.C. no injuries attributed to the problem are reported.
  • Action
    Software to be upgraded

Device

Philips Allura Xper FD and Allura Clarity x-ray systems
  • Model / Serial
    Model: 722003, 722005, 722006, 722008, 722010, 722012, 722013, 722015, 722023, 722026, 722028, 722035, 722058, Affected: , Software version: All (upgrades to) Allura XPER or AlluraClarity with software releases 1.2.7, or 2.0.6, or 7.2.x where x<8 or 7.6.x or 7.8.x or 8.1.x where x< 16 or 8.2.x where x<16
  • Manufacturer
    Philips Medical Systems Nederland BV

Manufacturer

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