Recall Z-0930-2018 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
Proteus 235, graphite block 8
| Date | Oct 17, 2017 |
| Status | Terminated |
| Reason | IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader |
| Root cause | Component design/selection |
| Action | On July 17, 2017 An Urgent Field Safety Notice was issued to customers with the following user action: In case a patient treatment plan requires the use of the block 8, it is recommended to perform a full range verification during the patient treatment plan QA check. After the replacement of the graphite block 8, it is recommended to verify there is no effect on the Bragg peak. |
| Quantity | 3 |
| Distribution | WA |
| 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 |