Events

Field Safety Notices about Monaco running version 3.1 and higher

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
    For certain workflows where you edit contours (zoom in, move, copy, etc.) and then delete and save the contour on some slices in the same session, deleted contours may still be present, which the planner did not intend. if you did not save and retrieve the patient, the contours in the beam view (bev) in the newly created contour plan will still be present and the contours, center, and front will be displayed as deleted. the total amount of structures displayed in dvh and in structure management does not match.

Device

Monaco running version 3.1 and higher

Manufacturer

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