Events

Field Safety Notices about MOSAIQ®

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 IMPAC Medical Systems, Inc. .

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
  • 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
    The machine characterization (mac) file contributes to the proper functioning of the mosaiq system and the elekta linear accelerator. patient safety is our top priority. elekta was aware of the possibility of incorrectly determining the characteristics of the bed value, which results in incorrect adjustment of the table position when using the couch move assistant (cma) feature in mosaiq. verification tests are attached to this notice. these tests must be performed before any further treatment of the patient.

Device

MOSAIQ®

Manufacturer

IMPAC Medical Systems, Inc.
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    AMPMDRS