Events

Field Safety Notices about deltastream MDC, i-cor and iLA active consoles

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 Medos Medizintechnik AG.

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 loudspeaker of the aforementioned consoles may fail upon activation of the alarm as a result of a technical fault with the diaphragms (cones). in this case no acoustic alarm is emitted. the simultaneous visual alarm display is output and is not affected by the fault. the fault may occur during system start- up (self-test), but also during therapy. .

Device

deltastream MDC, i-cor and iLA active consoles

Manufacturer

Medos Medizintechnik AG