Recall Z-1205-2022 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
| Date | May 27, 2022 (initiated Apr 20, 2022) |
| Status | Open, Classified |
| Reason | First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed |
| Root cause | Under Investigation by firm |
| Action | ***UPDATE 12/22/22*** Ion Beam Application S.A. (IBA S.A.) issued an Amended Urgent Medical Device Correction to customers starting December 22, 2022 (supersedes previous letter Sept 15, 2022). Letter provides quantitative data about the impact on the dose distribution, and the description of the solution (software upgrade) as well as the time schedule for its deployment. Cyclic check thresholds verification and software upgrade Additionally, IBA will provide each impacted customer with a report including: - The list of the Uniform Scanning fields with the first layer entirely delivered with |
| Quantity | 4 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of IL, VA, WA and the country of Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163500 | IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) Ion Beam Applications S.A., Aug 17, 2017 |