Safety Alert for ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 10345161980 Hazard Class: III Affected Model: Artis Zee Ceiling, Artis Zee Floor, Artis Zee Multi-purpose, Artis Zeego Serial Affected: 137159

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.

Users should notify and instruct their staff to be aware of this problem and if the equipment exhibits any adverse behavior prior to corrective action, the company's support service should be contacted. ### UPDATED ON 10/26/2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed. 2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.