Events

Field Safety Notices about Integrated Cycler System USB Cable Assembly 2M Ferrite

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 Focus Diagnostics.

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
    2015-11-24
  • 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
    Focus determined that the ics was not in compliance with a recently revised electromagnetic compatibility standard (emc), en 61326-12013, that is noted in the integrated cycler studio operator manual, preface — health and safety information (page xiii). for the ics to be in compliance with the current emc standard, focus will provide the usb cable assembly 2m ferrite to replace the existing usb cable. focus conducted tests to ensure the new usb cable assembly 2m ferrite meets the requirements of the revised emc standard.

Device

Integrated Cycler System USB Cable Assembly 2M Ferrite

Manufacturer

Focus Diagnostics