Events

Recall of Allura Xper FD Release 8.2.16(Flouroscopic x-ray used in angiography)

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-00995-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-10-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00995-1
  • 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
    Philips healthcare has discovered through customer feedback and internal testing a software failure that could lead to an intermittent and short term unavailability of the fluoroscopy function. upon initiating fluoroscopy the user may encounter a user message “fluoro failed, please retry” and fluoroscopy will be unavailable. retrying fluoroscopy resolves this situation in most cases. you may need to retry more than once in about 2% of the events.The failure mode has no impact on an active fluoroscopy run. once started, an active fluoroscopy run continues until releasing the pedal.
  • Action
    Philips is advising end users that they must retry fluoroscopy if the failure mode occurs. Philips Field Service Engineers will install Software R8.2.16.1 which will correct the issue. The expected date of the correction release is October 2015. This action has been closed-out on 26/08/2016.

Device

Allura Xper FD Release 8.2.16(Flouroscopic x-ray used in angiography)

Manufacturer

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