Field Safety Notices about Aquilion

According to Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems, this field safety notices involved a device in Czechia that was produced by Toshiba Medical Systems Corporation.

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
    392
  • Date
    2016-01-26
  • Event Country
  • Event Source
    MHSIDCCCDMIS
  • Event Source URL
  • Notes / Alerts
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 the Czech Republic.
  • Extra notes in the data

Device

  • Model / Serial
    Model Number: TSX-301B with system software V6.0 or later TSX-301C with system software V6.0 or later TSX-302A with system software V6.0 or later TSX-303A with system software V5.00*R000 or later TSX-101A with system software V6.0 or later TSX-201A with system software V6.0 or later TSX-032A with system software V6.0 or later TSX-033A with system software V6.0 or later TSX-034A with system software V6.0 or later TSX-035A with system software V7.0 or later
  • Product Description
    Medical devices for diagnostics and radiation therapy
  • Manufacturer

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    MHSIDCCCDMIS