Proteus 235 recall: Software Issue
Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Why was Proteus 235 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
PAT.108 (US), PAT.110 (US), PAT.113 (US), PAT.114 (EU), SAT.119 (US).
- Product
- Proteus 235; Version: PTS-8 versions before PTS-8.7.2
- Recalling firm
- Ion Beam Applications S.A.
- Quantity
- 5 devices
- Distribution
- IN USA: VA, OK, NJ, TN OUS: Czech Republic.
- Recall date
- January 19, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)