Events

Safety Alert for VISUM SURGICAL FOCUS. Anvisa Registry n ° 80005439007.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Stryker do Brasil Ltda..

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
    1104
  • Date
    2011-12-09
  • 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
    See letter to the attached users - http://portal.anvisa.gov.br/wps/wcm/connect/b1475480495cd0d3b5c0f54ed75891ae/Alerta_1104_Customer_Response_Formular.pdf?MOD=AJPERES.#### Update (07/17/2012): the company presented inspection reports regarding technical visits to customers for product inspection. Alert closed.
  • Reason
    Uncoupling the focus from your suspension arm, with the possibility of causing serious injury to patients or operators.
  • Action
    Risk communication to users of the product.

Device

VISUM SURGICAL FOCUS. Anvisa Registry n ° 80005439007.

Manufacturer

Stryker do Brasil Ltda.
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    ANVSANVISA