Events

Safety Alert for Controllers to Automate Autoclaves.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by N/A.

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
    699
  • Date
    2002-04-17
  • 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
    LAW No. 6.437 OF AUGUST 20, 1977 - (Published in the Official Gazette of 24 August 1977, page 11145) - Configures infractions to federal sanitary legislation, establishes the respective sanctions, and makes other provisions. Art. 10. Sanitary infractions: XVI - Change the manufacturing process of products subject to sanitary control, modify its basic components, name, and other elements subject to registration, without the necessary authorization from the competent sanitary body.
  • Reason
    Existence of companies in the market that automate autoclaves of any manufacturing, replacing the existing electromechanical controls, making the autoclave fully automatic without the necessary consent of the manufacturer and authorization of the competent sanitary body.
  • Action
    Do not accept that companies automate the autoclaves, with controllers, without the necessary consent of the manufacturer and authorization of the competent sanitary organ. ANVISA is supervising these companies.

Device

Controllers to Automate Autoclaves.
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA