Events

Field Safety Notices about Artis 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 Healthcare GmbH.

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
    2017-01-24
  • 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 artis systems with the software versions specified above, a semi-automatic focus switch is implemented. interacting with a special type of defect due to wear in the foci "small" and "micro" (if present). this performs an automatic focus switch when the footswitch is pressed several times. this special system function is not fully described in the operating instructions currently available. if a focus (small/micro) develops a defect, an alternative focus can be selected by pressing the footswitch several times. this enables radiation to be generated once again so that the clinical treatment or diagnosis can be continued.

Device

Artis systems

Manufacturer

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