Field Safety Notices about Ceiling pendant SPR 10

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 MZ Liberec a.s..

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
  • Event Country
  • Event Source
  • 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
    Following notification of an incident of failure of an axial segment of a ceiling pendant component, mz liberec is initiating a field safety corrective action. our company will substitute all the axial segments in the field for the new ones. you should receive these new parts along with this notice. we have also increased the inspections of these components as part of the manufacturing process to prevent reoccurrence of similar incidents in the future. it is important that all users inspect the axial segment components for excessive wear. if the any part of the segment has a thickness of less than 1.7 mm, users should cease using the product immediately.