Events

Field Safety Notices about ultrasound system ARIETTA Prologue

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 Hitachi, Ltd..

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
    2017-06-07
  • 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
    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.