Trade Name: E.CAM SIGNATURE SERIES; registration 10234230040; hazard class III ///// Trade Name: SYMBIA SPECT / CT EQUIPMENT; model: Symbia T; Symbia T2; Symbia T6; Symbia T16; registration 10345161973; risk class III //// Trade Name: SPECT SYSTEM; model: Symbia E; Symbia S; registration 10345161991; class of risk II 의 안전성 경고

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.

Recommendation to users and patients: Based on the results of our risk analysis, which indicates that the possibility of error is remote, we can continue to use the system. Make sure this notice is included in the instructions for use of the system. To reduce the chances of occurrence, follow the Shutdown and Startup instructions as described in the User's Guide. We also ask clients to wait for the update schedule to correct the error mentioned in the MI002-16-S Field Action Alert Message.