Events

Recall of Allura Xper FD10 F and Allura FD10/10 (diagnostic, fluoroscopic x-ray system)

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-2013-RN-00813-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-08-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00813-1
  • 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
    While the c-arc base rotation is moved manually and at the same time a motorised base rotation is initiated followed by a movement stop request the geometry of the system will reset. consequently the stand movements and table movements then will not be available for about 90 seconds. the table top will be free floating and can manually be moved in both longitudinal and transversal direction.
  • Action
    Philips is advising users not to initiate a motorised movement of the base rotation when it is moved manually. The system sees this as a conflict and will perform a Geo reset. A software update will be available in Quarter 4 2013.

Device

Allura Xper FD10 F and Allura FD10/10 (diagnostic, fluoroscopic x-ray system)
  • Model / Serial
    Allura Xper FD10 F and Allura FD10/10 (diagnostic, fluoroscopic x-ray system) Product Codes: 733001, 722002, 722003, 722005, 722010, 722011, 722014, 722019, 722123 & 722133ARTG Number: 98560
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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