Alerta De Seguridad para ARTIS EQUIPMENT FOR ANGIOGRAPHY. Anvisa Registry No. 10234230158. Affected Series: 10501, 25418, 35318, 35748, 35817, 35872, 35913, 135329, 135758, 135816, 135825, 135835, 135848, 135941, 136115, 136199, 136282, 136301, 136320, 136369, 136373 , 136419, 136908, 160143, 160360, 160415, 160457 and 160467.

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.

A certain component of the equipment - responsible for securing a pin to its original position - has not been adjusted correctly, which can cause the pin to come loose and leave some parts of the system loose, with the possibility of detaching. According to Siemens, the possibility of adverse events related to the operation of the system or the detachment and falling of parts, especially in the event of a collision with the equipment, can not be ruled out. The verification of the equipment has not yet been programmed by the company.