Reported Jan 19, 2022 · Terminated
Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Ion Beam Applications S.A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ion Beam Applications S.A. · Chemin Du Cyclotron 3 · Louvain-la-neuve, N/A · N/A
Is this the product you have?
- Proteus 235
- VersionPTS-8 versions before PTS-8.7.2
- Lot codes and dates
PAT.108 (US)PAT.110 (US)PAT.113 (US)PAT.114 (EU)SAT.119 (US)
- Amount recalled
- 5 devices
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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