Events

Safety Alert for Software, Xknife RT Radiosurgical System. Version 1.02 and below

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Radionics Inc A Tyco Healthcare Group Co.

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
    268
  • Date
    2002-01-18
  • 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
    An error in the software may cause incorrect jaw positioning of the system. the manufacturer initiated a telephone call (correction) on september 17 and 18, 2001. the firm did not provide any information to ecri.
  • Action
    Make sure you received a call from Radionics on September 17 or 18, 2001. Identify and isolate any affected product in your inventory. For more information, contact your local Radionics representative or 1 (781) 272-1233 in the USA.

Device

Software, Xknife RT Radiosurgical System. Version 1.02 and below

Manufacturer

Radionics Inc A Tyco Healthcare Group Co
  • Source
    ANVSANVISA