Food, drugs, devices › Ion Beam Applications S.A.
Device recall: Proteus 235; Version: PTS-8 versions before PTS-8.7.2
FDA enforcement event 89267 is a device recall by Ion Beam Applications S.A. of Louvain-la-neuve, N/A, initiated 29 Nov 2021 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 20 Feb 2024. Initiation: voluntary: firm initiated. Ion Beam Applications S.A. has 35 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Ion Beam Applications S.A., Louvain-la-neuve, N/A, Belgium.
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…"
Distribution
"IN USA: VA, OK, NJ, TN OUS: Czech Republic."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0466-2022 | Proteus 235; Version: PTS-8 versions before PTS-8.7.2 | 5 devices | Class II | Terminated | 19 Jan 2022 |
Context
Other enforcement events for Ion Beam Applications S.A.
All 35 events for Ion Beam Applications S.A.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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…"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "IN USA: VA, OK, NJ, TN OUS: Czech Republic."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 20 Feb 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.