Recall Z-0934-2018 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
Proteus 235, Uniform and Pencil Beam Scanning 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 patient
| Date | Dec 5, 2017 |
| Status | Terminated |
| Reason | An accessory (range shifter, ridge filter&) can be improperly inserted in snout 300x400 with one rail only and the proton therapy system can still operate. |
| Root cause | Device Design |
| Action | Ion Beam Applications (IBA) sent an Urgent Field Safety Notice dated December 5, 2017, to customers informing them of the issue and request that all users verify that the accessory is correctly inserted in snout 300x400 with both rails in the guide. A solution to this issue including a hardware modification will be deployed on or before March 31, 2018. For further questions, please call (215) 972-7985. |
| Quantity | 14 |
| Distribution | US Distribution to the states of : MA, FL, VA, PA, OK, TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060695 | IBA PROTON THERAPY SYSTEM - PROTEUS 235 Ion Beam Applications S.A., Apr 11, 2006 |