Events

Safety Alert for allura xper fd10/10

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

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
    2013-06-25
  • Event Date Posted
    2013-06-25
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130625.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 allura xper fd10/10 the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device alert concerning allura xper fd10/10, which is a biplane cardiovascular x-ray system manufactured by philips. all systems are affected. the medical device alert mentions that the table will reboot if users attempt a powered and manual movement at the same time. the reboot will take approximately 90 seconds during which time no motorised movement will be possible. this has led to delay during emergency treatment. basic imaging will still be available. the mhra reminds the superintendent diagnostic radiographers to identify the affected devices and inform users of the issue. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/publications/safetywarnings/medicaldevicealerts/ con286972 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 june 2013.

Device

allura xper fd10/10
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips Allura Xper FD10/10
  • Manufacturer
    Philips

Manufacturer

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