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Ion Beam Applications S.A. Recall 89267

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

Ion Beam Applications S.A. Recall 89267 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0466-2022
Event ID89267
Event DescriptionProteus 235; Version: PTS-8 versions before PTS-8.7.2
Product TypeDevices
DistributionIN USA: VA, OK, NJ, TN OUS: Czech Republic.
Quantity5 devices
Recall ReasonProton 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.
Device Classification20220119
Device Code InfoPAT.108 (US), PAT.110 (US), PAT.113 (US), PAT.114 (EU), SAT.119 (US).
Center Classification Date20220107
Recall Initiation Date20211129
Recalling FirmIon Beam Applications S.A.
Initial Notification Letter
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