Alerta De Seguridad para X-ray Generator, X-ray Generator Set (1) Model KXO-50R, (2) Model KXO-50F, Model KXO-80N

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.

BRASIL-03.10.2002 / Letter from the company Toshiba Medical do Brasil Ltda, C-0340RX.2002, dated 27.03.2002, informs that the corrections are already being carried out with customers with the X-ray generator, model KXO 50- F. In addition, it covers not only the referenced model, but also the KXO-30R, KXO-30F, KXO-50N and KXO-80N models. -------------------------------------------------- ---------------------- On July 29, 2002, C-084RX.2002, the company Toshiba Medical do Brasil Ltda, announces the closure of the adequacy procedures of generators. Circuit Modification as instructed by Toshiba Corporation, Medical Sistems Division (Field Modification Instruction FMI - XR863) to conform to international standard CFR1020.31.