Food, drugs, devices › Ion Beam Applications S.A.
Device recall: Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names: Proteus Plu
FDA enforcement event 79228 is a device recall by Ion Beam Applications S.A. of Louvain La Neuve, N/A, initiated 19 Oct 2017 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. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 2 Apr 2019. 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
"Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not."
Distribution
"US Distribution to the state of :FL"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0931-2018 | Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.… | 3 | Class II | Terminated | 14 Mar 2018 |
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: "Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not."
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: "US Distribution to the state of :FL"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 2 Apr 2019. "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.