Events

Field Safety Notices about ARIETTA 60 and ARIETTA 70

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
    2016-04-04
  • 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
    Screws of monitor arm for arietta 60 and arietta 70, which are supporting the 2 linch monitor, may become loose due to a design flaw, and as a result the monitor arm and the monitor may under rare circumstances drop off from the supporting arm.

Device

ARIETTA 60 and ARIETTA 70
  • Model / Serial
    203A5592 - 204J6824 V0006403 - V0011093 XOOC0944 - XO0C0959
  • Manufacturer
    Hitachi Ltd.

Manufacturer

Hitachi Ltd.