Events

Safety Alert for LEKSELL GAMMA KNIFE PERFECTION. Anvisa Registry n ° 80569320006.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Elekta Medical Systems Ltda; Elekta Instruments AB.

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
    1440
  • Date
    2014-10-21
  • 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
    There is a possibility that improper handling may occur due to incorrect positioning of the patient: if the coordinate structure is not locked correctly to the Frame Adapter, a gap can be created and possibly the target of the planned position can be shifted by up to 0.5mm . Check the Important Field Safety Notice issued by Elekta. The company reported that there are two equipment under risk in Brazil.
  • Reason
    Possible misalignment of the frame adapter structure of the device.
  • Action
    Verify instructions in the Important Field Safety Notice, at http://portal.anvisa.gov.br/wps/wcm/connect/402cca0045ea2ca69a27be7ffa9843d8/Assessment+Important+of+Security+-+ELEKTA.pdf?MOD= AJPERES

Device

LEKSELL GAMMA KNIFE PERFECTION. Anvisa Registry n ° 80569320006.

Manufacturer

Elekta Medical Systems Ltda; Elekta Instruments AB
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    ANVSANVISA