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Recall Observatory FDA recall evidence

Device product

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

Z-0466-2022

November 29, 2021

Class II

Product summary

Firm
Ion Beam Applications S.A.
Event
Event 89267
Status
Terminated
Classification
Class II
Quantity
5 devices
Official record key
device-enforcement:Z-0466-2022

Official wording

Reason: 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.

Code information: PAT.108 (US), PAT.110 (US), PAT.113 (US), PAT.114 (EU), SAT.119 (US).

Distribution pattern: IN USA: VA, OK, NJ, TN OUS: Czech Republic.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software can