Events

Avis De Sécurité sur ultrasound system ARIETTA Prologue

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 Hitachi, Ltd..

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
  • Date
    2017-06-07
  • 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
    Operation of arietta prologue becomes unstable due to contact failure between backend unit (be, screen side) and frontend unit (fe, probe connection side). this may cause the following malfunctions: - the monitor of be is once disappeared and return to the home screen display. - the connection of probe isn’t recognized. - it doesn’t charge the battery of be in spite of setting the battery cutoff switch to enable mode. - it doesn’t charge the battery of be in spite of setting the battery cutoff switch to enable mode. - although fe and be are connected as wired communication, it is recognized as wireless and an alarm would occur. - it would stop the scanning during the examination and returns to the home screen display. - it would freeze the ultrasound image during the scanning (screen update would stop). ' - the communication between fe and be would be lost and fe will finally shut it down. - a hardware error message would be displayed when the machine boots up.

Device

ultrasound system ARIETTA Prologue

Manufacturer

Hitachi, Ltd.