Recall Z-0931-2018 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
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. The PTS may include a fixed small beam treatment room dedicated to the treatment o
| Date | Oct 19, 2017 |
| Status | Terminated |
| Reason | Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not. |
| Root cause | Device Design |
| Action | IBA sent an Urgent Field Safety Notice dated October 19, 2017 , issued to customers stating the following: IBA recommends performing a check to detect the consequence of this potential power supply regulation issue on a regular basis (IBA recommends Monthly), see Annex 1 for details. IBA is developing a corrective action in order to reduce the hysteresis effect and detect magnet current overshoot. This solution will be deployed to all systems using JEMA analog power supply. This solution will be validated and deployed by April 2018. For further questions, please call (215) 972-7985 |
| Quantity | 3 |
| Distribution | US Distribution to the state of :FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082416 | IBA PROTON THERAPY SYSTEM- PROTEUS 235 Ion Beam Applications S.A., Dec 12, 2008 |