Alerta De Seguridad para EQUIPMENT FOR ANGIOGRAPHY AXIOM ARTIS. ANVISA Registry: 10234230096 (Model FA). Affected Models: FA, FC, dFC, dTC, dFA and dTA.

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.

Siemens Ltda informed the ANVISA's Technovigilance Unit (UTVIG / ANVISA) that has already sent a communication letter to its customers, reporting the problem and advising on the necessary actions. The company also reported that it intends to update all AXIOM ARTIS systems that cause the problem reported in this alert, but has not yet reported the start date of the field action to be performed. #### Update on 04/20/2012: Accordingly with communication sent on 04/17/2012 by the company to UTVIG / ANVISA (file no. 0324770128, 04/19/12), the field action has already been finalized - software correction. The company reported that it performed the correction on ten equipments installed in Brazil.