Recall Z-1492-2014 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy
| Date | Apr 24, 2014 (initiated Dec 4, 2013) |
| Status | Terminated |
| Reason | Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0). |
| Root cause | Software design |
| Action | Ion Beam Applications ( IBA) sent a recall notification letter dated on/about December 5, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Short term action: A user notice (see annex 1) has been sent to impacted sites where the affected legacy PTS software version was delivered. This user notice explains the workaround required to be put in place in order to fully mitigate the risk and the 1BA action plan to permanently fix this issue. Corrective action: A patch on the PTS Legacy SW was requested and in impleme |
| Quantity | 4 |
| Distribution | US Distribution including the states of OK, IL, NJ, and WA. |
| 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 |