Alerta De Seguridad para Allura Xper Angiography Equipment Technical Name: Angiography Equipment ANVISA Registration Number: 10216710153 Hazard Class: III - High Risk Affected Models: 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: 45, 53, 139, 170, 180, 123, 263, 173, 174, 195, 179.

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. #### Update of the field action: UPDATED ON 12/11/2017, the company presented the completion report of the field action, with sending of necessary evidences and corrective actions. 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