Events

Safety Alert for Leksell Gamma Knife® ## ANVISA Record Number: 80569320006 ## Risk Class: III ## Affected: Leksell Gamma Knife PERFEXION ## Serial Number (s) To Handle: LEKSELL GAMMA KNIFE PERFEXION / 17397-001 / 6158 and LEKSELL GAMMA KNIFE PERFEXION / 105528-001 / 6122.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Elekta Medical Systems Comércio e Serviços para Radioterapia Ltda; Elekta Instrument 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
    1865
  • Date
    2016-04-14
  • 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 company points out that "The customer (technician) should read the manual and follow exactly the guidelines on page 44 item 3.3.1. If in doubt, consult the Elekta technical service."
  • Reason
    Potentially incorrect mounting of the frame adapter to the stereotactic head-frame may affect product performance. if the frame adapter is placed incorrectly (large displacement) in the stereo head frame, the treatment will fail the target with approx. 1-2 cm. that is, if the frame adapter is incorrectly mounted to the coordinate frame and this is not noticed by the user before the start of treatment, the dose will be delivered in the wrong place.
  • Action
    Company unleashed Field Action - Security Alert - with the sending of a communication to customers (LETTER TO CUSTOMERS IN ANNEX). Code FCA-EIAB-0004 ## Two units of the equipment have been imported: LEKSELL GAMMA KNIFE PERFEXION / 17397-001 / 6158; LEKSELL GAMMA KNIFE PERFEXION / 105528-001 / 6122 sold respectively to the Heart Hospital of São Paulo (HCOR) and to the company JR Camargo & OO Kaesemodel Filho of Curitiba / PR.

Device

Leksell Gamma Knife® ## ANVISA Record Number: 80569320006 ## Risk Class: III ## Affected: Leksell...

Manufacturer

Elekta Medical Systems Comércio e Serviços para Radioterapia Ltda; Elekta Instrument AB
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    ANVSANVISA