Events

Recall of Allura Xper R8.2.0 (Fluoroscopic diagnostic 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-2014-RN-00812-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-07-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00812-1
  • 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
    As result of a faulty automatic motion controller (amc), a problem in the power on self test (post) error handling was detected, which can result in a hazardous movement of the c-arc. this can only occur during startup of the system. when the problem in the post error handling during startup occurs, the c-arc might move unexpectedly. the image detector (which is connected to the same amc axis motion controller) may also move unexpectedly. the issue does not occur at every startup and is only present if a post-error handling is detected during the post phase.
  • Action
    Philips is advising that the user must be cautious for any unexpected movement of the C-arc and Image Detector when a system start-up (cold restart) is required during a procedure to protect their own safety and the safety of the patient on the table. Philips field service engineers will install software release R8.2.0.3 which addresses the Positioning Software to respond properly to this error reported by the AMC motion controller during startup of the system. This action has been closed on 05/08/2016.

Device

Allura Xper R8.2.0 (Fluoroscopic diagnostic x-ray system)

Manufacturer

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