FDA-Device2022-01-19Class II

Proteus 235; Version: PTS-8 versions before PTS-8.7.2

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.

Sold states
IN USA: VA, OK, NJ, TN OUS: Czech Republic.
Affected count
5 devices
Manufactured in
Chemin Du Cyclotron 3, N/A, Louvain-la-neuve, N/A, Belgium
Products
Proteus 235; Version: PTS-8 versions before PTS-8.7.2

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0466-2022

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief