Events

Recall of Allura Xper and Allura Clarity - 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

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-2015-RN-01104-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-11-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01104-1
  • 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
    It has been discovered through customer complaints and internal testing that there is an intermittent electronic product defect. in certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound. no injuries attributed to the problem have been reported.
  • Action
    The sponsor will perform a software update to the affected devices. In the meantime, the user is advised to always observe real time dose information and cumulative fluoro time provided by the system. The fault condition is reset when a new patient case is started or when the system is restarted. This action has been closed-out on 05/12/2016.

Device

Allura Xper and Allura Clarity - software releases 1.2.7, or 2.0.6, or 7.2.x where x<8 or 7.6.x o...
  • Model / Serial
    Allura Xper and Allura Clarity - 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<16Product Codes: 722026, 722027, 722028, 722029, 722038, 722058, 722033, 722034, 722035, 722036, 722039, 722059, 722003, 722005, 722006, 722008, 722010, 722012, 722013, 722015, 722023.Allura Xper FD R2.xProduct Code: 722006Allura Xper FD R8.2.0 Product Code: 722035ARTG Number: 175708
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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