Events

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

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par FUJIFILM.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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)
  • Modèle / numéro de série
  • Manufacturer
    FUJIFILM

Manufacturer

FUJIFILM