Recall Z-2684-2017 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 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 tumors and other con
| Date | Dec 13, 2016 |
| Status | Terminated |
| Reason | Software issue |
| Root cause | Software design |
| Action | An Urgent Field Safety Notice was mailed to affected customers to inform them of the issue. The notice indicated possible software failure, the associated risks and actions users should implement to correct the issue. IBA plans to follow-up with a software update which will be deployed on impacted sites to correct this issue. |
| Quantity | 6 worldwide and 5 in the U.S. |
| Distribution | Distributed to FL, VA, IL, NJ, WA and South Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152224 | Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) Ion Beam Application S.A., Aug 9, 2016 |