Recall Z-0698-2019 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
Proteus 235 Product Usage: 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tu
| Date | Dec 12, 2018 |
| Status | Terminated |
| Reason | There is a risk of detachment of the Compact Gantry Rolling Floor. |
| Root cause | Device Design |
| Action | On December 12, 2018, the firm notified its customers of the recall via an Urgent Medical Device Correction letter. Customers were informed of the product issue. Customers were reminded that nobody should stand on the rolling floor when the gantry is rotating, as specified in the Clinical User Guide. The recalling firm stated they would take the following actions: Short-term action: IBA will replace the rod end bearings attaching the cGRF to the nozzle via a preventive maintenance on all ProteusONE sites. Long-term action: A new design of the anchoring system of the cGRF to the nozzle will |
| Quantity | 7 |
| Distribution | Worldwide Distribution - US Nationwide in the states of LA and MI. Foreign distribution to France, Japan, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091629 | PROTEUS 235 PROTON THERAPY SYSTEM Ion Beam Applications S.A., Aug 11, 2009 |