Alerte De Sécurité sur ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 10345162023 Hazard Class: III Model Affected: Artis zee ceiling Serial Numbers Affected: 17582

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 recommends the use of sterilized covers to protect the wireless radar drive pedal from all types of contamination. Since it is already standard practice in many installations, this approach is an effective way to prevent the wireless radius trigger pedal from coming into contact with liquids. When cleaning or disinfecting the radiation trigger pedal, use cloths that are moist but not dripping. You should avoid immersing the wireless radiation trigger pedal into liquids until corrective action has been taken. If the wireless radiation trigger pedal stops working, the radiation delivery for acquisition of images continues to be possible via the manual radiation trigger pedal. Normal emergency procedures should be implemented in case of system failure. Ensure that these processes are prepared in advance until our countermeasures have been implemented. There is no need to re-examine any patients. This is a possible hardware defect that has no influence on the treatment of patients. ### 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.