Events

Safety Alert for VITREA IMAGE PROCESSING SOFTWARE. Anvisa Registry n ° 80047300169. All versions of Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX earlier than version 6.3.3.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA.; VITAL IMAGES INC..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1302
  • Date
    2013-10-04
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Extra notes in the data
    Check for additional information in the Alert Message released by the product registration holder, available at http://portal.anvisa.gov.br/wps/wcm/connect/97107200415616e5ac03afa8d08ea2d4/Carta+Cliente.pdf?MOD=AJPERES.
  • Reason
    Error related to the measurement, which occurs when the images are rotated at the time of the reconstruction by the scanner.
  • Action
    Software update.

Device

VITREA IMAGE PROCESSING SOFTWARE. Anvisa Registry n ° 80047300169. All versions of Vitrea Enterpr...

Manufacturer

MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA.; VITAL IMAGES INC.
  • Source
    ANVSANVISA