Events

Field Safety Notices about FUJIFILM Digital Mammography System AMULET f/s(FDR MS-2500/2000), AMULET Innovality(FDR MS-3500)

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
    There was a case that the swivel arm went down unintentionally when it was moved up/down. based on the investigation result, it has been determined that the possibility of occurrence in other devices is very low. however, in order to further enhance the safety, improvement is made as a voluntary field correction to prevent the swivel arm from going down unintentionally in all the devices having the same structure. while the probability that a problem occurs is very rare; fujifilm wishes to reduce any potential risk to patients as soon as possible.

Device

FUJIFILM Digital Mammography System AMULET f/s(FDR MS-2500/2000), AMULET Innovality(FDR MS-3500)

Manufacturer

FUJIFILM