Alerta De Seguridad para Linear Primus Accelerator; Oncor Linear Accelerator; Linear Accelerator digital ARTISTE; X-ray System for Mevatron M. Therapy (10234230073; 10234230125; 10234230172; 10234230021)

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.

If the FILM (MOVIE) mode for image acquisition is used even if it is not correctly calibrated, it may cause overdose in the patient. Clients will be instructed to calibrate and verify each beam intended for use in patient care or image acquisition in accordance with the procedure described in the customer letter and its annex. In addition, customers will be advised to keep the letter about the potential problem in the owner's manual and to complete the questionnaire attached to the letter to the customer. Link - Letter to the client: http://portal.anvisa.gov.br/wps/wcm/connect/77a060004069139183c1d3dc5a12ff52/Carta_TH02213S.pdf?MOD=AJPERES and http://portal.anvisa.gov.br/wps/wcm/ connect / 70b41780406912d5839ad3dc5a12ff52 / Anexo_da_Carta_TH02213S_Portugues.pdf? MOD = AJPERES