Proteus 235; Version: PTS-8 versions before PTS-8.7.2
FDA Recall #Z-0466-2022 — Class II — November 29, 2021
Product Description
Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Reason for Recall
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.
Recalling Firm
Ion Beam Applications S.A. — Louvain-la-neuve, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
5 devices
Distribution
IN USA: VA, OK, NJ, TN OUS: Czech Republic.
Code Information
PAT.108 (US), PAT.110 (US), PAT.113 (US), PAT.114 (EU), SAT.119 (US).
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.