Events

Field Safety Notices about DXR

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Philips Medical Systems.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-07-14
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Because reliability and safety are always at the forefront of philips, we regularly monitor the performance of our products. during recent assessments of the mobile detector holder, we have identified a possible defect that may affect the performance of the equipment under certain conditions. we would like to inform you of the following letter:   • what is the disadvantage and under what conditions it may occur, • what measures can be taken to prevent or limit the problem, • what actions philips will address the shortcoming.

Device

DXR

Manufacturer

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