Events

Field Safety Notices about FDR-1000AWS / FDR-2000AWS / FDR-3000AWS / CR-IR363AWS

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 FUJIFILM.

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 identified a potential failure with our mammography system. in very rare cases, v5.0, v5.1, v5.2, v6.0, v6.1, and v7.0 software for workstation fdr-1000aws/fdr-2000aws/fdr-3000aws/cr-ir363aws possibly assign the duplicated id number to exposure images. if an image with this error is transmitted to pacs, it may overwrite the image already stored on pacs. fujifilm has corrected the software that is the cause of such failure.

Device

FDR-1000AWS / FDR-2000AWS / FDR-3000AWS / CR-IR363AWS

Manufacturer

FUJIFILM