Events

Recall of Philips BV25, BV300, BV Libra, BV Endura, BV Pulsera (Fluoroscopic x-ray systems)

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-2016-RN-01183-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-09-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01183-1
  • 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 has been notified regarding an issue with the x-ray "on" label for systems supplied in south australia. the colour of the exposure indicator on the control panel is same as the background text. hence, systems do not meet south australia's radiation protection and control regulation.This issue has been evaluated for radiation hazard and concluded that there is no safety impact to the patient, user or bystander. it is a regulatory non-compliance issue in south australia. this issue has been evaluated for potential radiation hazard and concluded that there is no safety impact to the patient, user or bystander.
  • Action
    Philips will be applying a red transparent label over the existing x-ray symbol on the control panel as a permanent correction in the affected systems in South Australia. In the interim, users are advised that there is an indicator lamp on Mobile Viewing Station which glows whenever x-ray exposure happens. The user should use this indication to be able to know when an exposure happens. This action has been closed-out on 24/05/2017.

Device

Philips BV25, BV300, BV Libra, BV Endura, BV Pulsera (Fluoroscopic x-ray systems)
  • Model / Serial
    Philips BV25, BV300, BV Libra, BV Endura, BV Pulsera (Fluoroscopic x-ray systems)System: BV25Model Number: 718015System: BV300Model Numbers: 71815, 71816, 71819System: BV LibraModel Numbers: 718022, 718030, 718031System: BV EnduraModel Numbers: 718071, 718072, 718073, 718074System: BV PulseraModel Number: 718094ARTG Number: 98556
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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