Events

Safety Alert for pedal of footswitch for philips multidiagnost eleva fd systems and allura xper systems

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Philips Healthcare.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-07-11
  • Event Date Posted
    2014-07-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140711.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: pedal of footswitch for philips multidiagnost eleva fd systems and allura xper systems medical device manufacturer, philips healthcare, has issued a field safety notice concerning its footswitches for multidiagnost eleva fd systems and allura xper systems. according to the manufacturer, if a footswitch is frequently used on an anti-fatigue mat, on a not flat surface or in the pedestal, the footswitch pedals may get bent. this might cause an intermittent or continuous inability of making live fluoro images or exposures. in case the fluoro pedal is bent and live fluoro is not available, the exposure pedal of the footswitch or the handswitch may be used to generate a live image in order to finish a procedure. this will lead to a higher dose but it outweighs a possible safety risk. the manufacturer advises users that before the start of a procedure, the footswitch should be inspected for possible bent pedals. if bent pedals are found, the procedure should not continue. furthermore, the manufacturer would arrange a mechanical hardware update of the footswitch in order to prevent bent pedals. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 11 july 2014.

Device

pedal of footswitch for philips multidiagnost eleva fd systems and allura xper systems
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Pedal of footswitch for Philips MultiDiagnost Eleva FD Systems and Allura Xper Systems
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DH