Recall Z-1695-2017 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
Proteus 235
| Date | Mar 23, 2017 (initiated Mar 9, 2017) |
| Status | Terminated |
| Reason | The Proton Therapy System can allow gantry rotation even if the snout is not properly locked. |
| Root cause | Component design/selection |
| Action | A Field Safety Notice was mailed or handed to affected customers to inform them of the issue. The notice provides information on the issue, the risk for the patient and user and actions to be taken before starting gantry rotation. Corrective action developed by IBA are detailed. |
| Quantity | 8 worldwide, 4 in U.S. |
| Distribution | Distributed in MA, FL, VA, and TN. China, South Korea, France and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101508 | MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 Ion Beam Applications S.A., Aug 6, 2010 |