Events

Safety Alert for Allura Xper Radiographic 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
    2014-07-09
  • Event Date Posted
    2014-07-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140709.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: philips healthcare allura xper radiographic systems medical device manufacturer, philips healthcare, has issued a field safety notice concerning its allura xper radiographic systems. according to the manufacturer, as a 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. when the system is used to perform clinical interventional procedures, this might cause a harmful situation in which the patient or staff member is being touched by the moving part. the manufacturer advises that 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 his own safety and the safety of the patient on the table. the manufacturer would provide updated software release r8.2.0.3 which addresses the positioning software to respond properly to this error. 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 09 july 2014.

Device

Allura Xper Radiographic 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