Events

Safety Alert for SV420P - Smith & Nephew Video Camera Control Unit (1) 420-8010, 420-8011, 420-8013,420-8026, 420-8028,420-8059, 420-8112, 420-8115, 420-8118 , 420-8120, 420-8132,420-8138, 420-8140,420-8146, 420-8149, 420-8151, 420-8152, 420-8154, 420-8155, 420-8161. 2) 420-8271, 420-8757, 420-8277, 420-8282, 420-8283, 420-8285, 420-8289, 420-9000,420-9002, 420-9004, 420-9010, 420-9012, 420-9019

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

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
    876
  • Date
    2007-06-29
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    Possibly does not meet the requirements for the electrical "transients" of cei (international electrotechnical commission) standard 60101.
  • Action
    The distributor initiated action for withdrawal from the market through the letter dated January 2007.

Device

SV420P - Smith & Nephew Video Camera Control Unit (1) 420-8010, 420-8011, 420-8013,420-8026, 420-...

Manufacturer

Smith & Nephew
  • Source
    ANVSANVISA