Recall archive / FDA device enforcement
Proteus 235; Version: PTS-8 versions before PTS-8.7.2 — FDA record Z-0466-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 29, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Proteus 235; Version: PTS-8 versions before PTS-8.7.2
- 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.
- Classification
- Class II
- Recalling firm
- Ion Beam Applications S.A.
- Quantity
- 5 devices
- Agency-reported status
- Terminated
- Source record identifier
- Z-0466-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | PAT.108 (US), PAT.110 (US), PAT.113 (US), PAT.114 (EU), SAT.119 (US). |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
IN USA: VA, OK, NJ, TN OUS: Czech Republic.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 19, 2022
- Recall initiation date
- Nov 29, 2021
- Center classification date
- Jan 7, 2022
- Termination date
- Feb 20, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.