Events

Safety Alert for Information System, Information System, Computer, Laboratory Softbank

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by SCC Clinical Information Systems.

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
    181
  • Date
    2000-11-10
  • 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
    In the systems above, there is no way to ensure that transactions in the adt interface correctly include patient data. the manufacturer initiated a correction by letter dated february 28, 2000. the company did not provide any information to ecri.
  • Action
    Make sure you have received the correspondence sent on February 28, 2000 from SCC Clinical Information Systems. Identify and isolate any affected product from your inventory. For more information, contact your local representative or directly with SCC Clinical Information Systems at 1 (727) 789-0100 in the United States.

Device

Information System, Information System, Computer, Laboratory Softbank

Manufacturer

SCC Clinical Information Systems
  • Source
    ANVSANVISA