Alerta De Seguridad para AXIOM Luminos dRF Fluoroscopic X-ray System, Record No. 10234230153. Series numbers affected in Brazil: 3141; 3142; 3144; 3174; 4248; 4255

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.

The company informs that the investigation conducted has determined that the described problem has been reproduced in cases of electrostatic discharge of more than 8kV that may be caused by a person close to the control console of the equipment. Only under extremely dry air conditions combined with a highly insulated floor can unintentional movement of the equipment be caused. However, the equipment meets the ESD safety requirements, according to IEC 61000-4-2 (36.202-2 Electrostatic discharge according to basic standard (+/- 6kV contact and +/- 8kV air).) Based on research and risk mitigation conducted by the manufacturer, it was detected that the root cause was that electrostatic discharges higher than 8kV can sporadically cause disturbances to the joystick sensors and consequently cause unintentional movements, such as inclination, and the probability of occurrence was considered improbable and its moderate severity, which fits this situation as a medium risk to health.As a corrective measure, Siemens is preparing an update to the control console of the Luminos dRF equipment in order to solve this potential malfunction. was identified on 2 devices within the overall installed base.