Events

Safety Alert for AFTERLOADER FOR BRAKING HDR GAMMAMED IX. Anvisa Registration No. 10405410015.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by VARIAN MEDICAL SYSTEMS HAAN GMBH (Alemanha). VARIAN MEDICAL SYSTEMS BRASIL..

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
    1611
  • Date
    2015-06-24
  • 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
    The manufacturer detected a discrepancy in the absolute dose rate provided with the Leipzig Style Applicator's Instructions for Use (IFU). Check additional information in the Urgent Field Safety Notice.
  • Reason
    The use of the published dose rate in the instructions for use, unmodified, may result in a dose administration of approx. 14% higher than intended to a depth of 5mm.
  • Action
    Update of instructions for use by the company. Users are advised to STOP the published dose rate on the Leipzig Style Cone Applicator Set, IFU GM11010080: Dose Characterization GM11010080 06-09-2012. For detailed instructions on how to proceed, check the Varian Urgent Field Safety Warning at: http://portal.anvisa.gov.br/wps/wcm/connect/3789590048dd5e6994a49fc758bf9f01/Assessment+of+Security%3C3% A7a_BT01836.pdf? MOD = AJPERES

Device

AFTERLOADER FOR BRAKING HDR GAMMAMED IX. Anvisa Registration No. 10405410015.

Manufacturer

VARIAN MEDICAL SYSTEMS HAAN GMBH (Alemanha). VARIAN MEDICAL SYSTEMS BRASIL.