Recall Z-0466-2022 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
Proteus 235; Version: PTS-8 versions before PTS-8.7.2
| Date | Nov 29, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 5 devices |
| Distribution | IN USA: VA, OK, NJ, TN OUS: Czech Republic. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163500 | IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) Ion Beam Applications S.A., Aug 17, 2017 |