Alerta De Seguridad para Product Category: Angiography Equipment Allura Xper. Technical Name: Angiography Equipment. ANVISA registration number: 10216710153. Class of risk: III - High Risk. Models Affected: ALLURA XPER FD10 OR table; ALLURA XPER FD20 OR table; ALLURA XPER FD10 (ground); ALLURA XPER FD10 (ceiling); ALLURA XPER FD20 (ground); ALLURA XPER FD20 (ceiling). Series Affected: See below

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.

This non-compliance with 21CFR1020.32 (h) (2) (ii) and IEC 60601-2-54, clause 203.6.2.1.c., does not directly cause a hazardous situation. However, the beep is one of the tools available to help prevent unnecessary radiation to the patient. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link