Events

Field Safety Notices about Symbia E and e.cam systems

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 Siemens.

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
    We have received complaints regarding incidents where collimator change activities have resulted in operator injury. our investigation found that these incidents may have been avoided by operators properly following specified instructions. the system was designed to safely store and exchange col mators, however ifthe instructions are not followed serious injuriesi such as broken bones and lacerations, may occur. we have determined that although the existing user manual is correct, additional supplemental instructions, with the inclusion of visual aids, may further clarify and emphasize the proper co imator change process.

Device

Symbia E and e.cam systems
  • Model / Serial
  • Manufacturer
    Siemens

Manufacturer

Siemens
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    AMPMDRS