Proteus 235; Version: PTS-8 versions before PTS-8.7.2
- Recall Initiated
- November 29, 2021
- Terminated
- February 20, 2024
- Recall Number
- Z-0466-2022
- Quantity
- 5 devices
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.
Distribution
IN USA: VA, OK, NJ, TN OUS: Czech Republic.
Lot / Code Info
PAT.108 (US), PAT.110 (US), PAT.113 (US), PAT.114 (EU), SAT.119 (US).
Root Cause
Device Design
Action Taken
A Urgent Medical Device Correction notification, Ref: IBA PR-121508, was communicated to all impacted IBA customers (users of the device) on Dec 6, 2021. Action to be taken by user: 1. Please transfer this notice to other organizations on which this action has an impact. 2. Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. 3. Please return the copy of the Urgent Medical Device Correction signed to IBA within 10 working days. Action by IBA: 1. IBA will upgrade the PTS version of each impacted site to a PTS version equal or superior to PTS-8.7.2. The PTS version upgrade will be deployed on your site by August 2022. 2. From PTS-8.7.2, the startup of the PTS software in the clinical environment is blocked if the shutdown of any process running in the test environment has not been successful. A message is displayed to request IBA operator to manually stop the remaining processes running in the test environment. Until the solution is implemented on your site, IBA operation team will ensure that any process running in the test environment is correctly shut down before each startup of the PTS in the clinical environment. for any question, contact Sylviane BERGER, Vigilance@iba-group.com, +32 10 203 787 or helpdesk +32 2 507 20 81 (available 24/7.