PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: January 19, 2022 Initiated: November 29, 2021 #Z-0466-2022

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.

Details

Units Affected
5 devices
Distribution
IN USA: VA, OK, NJ, TN OUS: Czech Republic.
Location
Louvain-la-neuve, N/A

Frequently Asked Questions

What product was recalled? ▼
Proteus 235; Version: PTS-8 versions before PTS-8.7.2. Recalled by Ion Beam Applications S.A.. Units affected: 5 devices.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 19, 2022. Severity: Moderate. Recall number: Z-0466-2022.

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