Events

Safety Alert for Practix Convenio Mobile X-ray System

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

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
    2012-05-31
  • Event Date Posted
    2012-05-31
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120531.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 practix convenio mobile x-ray system medical device manufacturer, philips medical systems issued a safety alert concerning practix convenio mobile x-ray system with serial number pc1-0504 through pc1-0588. philips warned that when the affected systems are switched off or when the tube arm is parked into its designated parking position (x-ray generator switch off), a radiation pulse (50 kv, 2.5 μgy) is inadvertently generated. this occurs on a small number of systems with a particular electronic component on the controller board. according to philips, there is a potential that the radiation from this extra x-ray pulse might reach a person in the vicinity of the system, resulting in unintended exposure. this extra radiation may also cause artifacts on x-ray images, if a cassette was in the path of the radiation. philips supplemented that the controller board of the affected systems will be updated later. meanwhile, the affected users are advised to completely close the shutters of the collimator before switching off the system and before bringing the tube assembly to its parking position. according to the local supplier, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted 31 may 2012.

Device

Practix Convenio Mobile X-ray System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips Practix Convenio Mobile X-ray System
  • Manufacturer
    Philips Medical Systems

Manufacturer

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