Events

Field Safety Notices about Vivid E95/E90/E80 with software version 201, revision 54.0 and 61.0. / Vivid S70/S60 with software version 201, revision 55.0 and 63.0. / Vivid S70N/S60N with software version 201, revision 63.0.

According to Bundesinstitut für Arzneimittel und Medizinprodukte, this field safety notices involved a device in Germany that was produced by GE Healthcare.

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 ID
    03021/17
  • Date
    2017-03-30
  • Event Country
    Germany
  • Event Source
    BAM
  • Event Source URL
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/19/2017/03021-17_Kundeninfo_en.html
  • Notes / Alerts
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
  • Extra notes in the data

Device

Vivid E95/E90/E80 with software version 201, revision 54.0 and 61.0. / Vivid S70/S60 with softwar...
  • Model / Serial
  • Product Description
    Ultrasonics - ultrasonic diagnostic equipment
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare