Events

Recall of Allura Xper, Allura Clarity & Integris

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-01124-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-11-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01124-1
  • 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
    The user may misinterpret still images as live images under following circumstances:1. if while performing fluoroscopy, the user also depresses the single shot exposure pedal, resulting in a single shot still image being acquired and displayed on the screen. the live fluoroscopy is not resumed until the single-shot exposure pedal is released. 2. on systems with multiple fluoroscopy pedals and modes (such as biplane systems), if while fluoroscopy is active in one mode, the user also depresses a second fluoroscopy pedal for a different mode and then releases the first fluoroscopy pedal, the system will stop live imaging and display a still last image hold ) image.Then the device ignores the second pedal until both fluoroscopy pedals have been released.Mistakenly interpreting still images as live images during interventional or diagnostic procedures can lead to unintended positioning of interventional and diagnostic devices and potentially resulting in patient injury or death.
  • Action
    Philips is advising the users to follow the instructions given in the customer letter and the IFU when operating the device as follows: - Be aware of the indicators related to X-ray on as described in the Instructions for Use (IFU). - Be aware that it is not possible to perform fluoroscopy and exposure at the same time. - USE ONLY ONE PEDAL at a time for image acquisition OR live imaging. - Be aware that pressing a single shot exposure pedal results in a still exposure image being displayed. No new image is acquired as long as the single shot exposure pedal remains pressed. - Always release the activated x-ray pedal after completion of image acquisition. - Philips recommends the usage of an audible signal (X-ray buzzer) during live imaging. If your X-ray buzzer has been disabled, contact Philips if you decide to enable it as an additional safety precaution. Philips is working with the TGA to determine whether any further risk mitigation actions are required. This action has been closed-out on 04/05/2017.

Device

Allura Xper, Allura Clarity & Integris
  • Model / Serial
    Allura Xper, Allura Clarity & IntegrisMultiple Product names affectedAllura System product codes 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722019, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722034, 722035, 722038, 722039, 722058, 722400.Integris product codes72238, 72239, 72240, 72241, 72242, 72243 ,72244, 72245, 72246, 72247, 72248, 72249, 722021, 722030, 722043, 722044ARTG # 175708, 98560
  • Product Classification
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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