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Ion Beam Applications S.A. recalls Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Recalled January 19, 2022 · FDA recall Z-0466-2022 · Ion Beam Applications S.A
Hazard
Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the clinical processes in the environment is not prevented even if some processes of the test environment (tcs) are still running. It may lead to situations where the system is using test processes without notifying the clinical user. If the versions of the processes are different between both environments, this could have an impact on patient treatments. · FDA Class II
Units
5 devices
Sold at
IN USA: VA, OK, NJ, TN OUS: Czech Republic.
Description
Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the clinical processes in the environment is not prevented even if some processes of the test environment (tcs) are still running. It may lead to situations where the system is using test processes without notifying the clinical user. If the versions of the processes are different between both environments, this could have an impact on patient treatments.
Product
Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Manufacturer(s)
Ion Beam Applications S.A.
Made in
Belgium
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →