Events

Safety Alert for X-ray Generator, X-ray Generator Set (1) Model KXO-50R, (2) Model KXO-50F, Model KXO-80N

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Toshiba America Medical Systems Inc.

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
    676
  • Date
    2001-10-26
  • 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
    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.
  • Reason
    The above x-ray controls / generators did not meet the 21 cfr 1020.31 (a) (2) requirements since uninterrupted exposure may occur as a result of tube bending. the manufacturer initiated a correction by letter dated july 19, 2001.
  • Action
    Verify receipt of letter and safety instructions from Toshiba America Medical Systems x-ray generator dated July 19, 2001. Identify all affected products in your inventory. Follow the instructions for safety use of the x-ray generators. For more information, contact your legal representative.

Device

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

Manufacturer

Toshiba America Medical Systems Inc
  • Source
    ANVSANVISA