Recall Z-0295-2024 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
| Date | Nov 14, 2023 (initiated Sep 18, 2023) |
| Status | Open, Classified |
| Reason | The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices. |
| Root cause | Device Design |
| Action | An Urgent Medical Device Correction issued on October 4, 2023 by email or in-person visit. Waiting for the solution to be deployed, IBA requires the user to only request jog translation motions to recover from a collision situation. IBA also recommends the user to post the notice near the device to remind them of this requirement until the software correction can be deployed. IBA provide an updated Urgent Medical Device Correction notification by November 30, 2023 with a target date for deployment of the software solution to your site. Customers are to complete and return the acknowledgement f |
| Quantity | 5 (US), 9 (OUS) |
| Distribution | Worldwide - US Nationwide distribution in the states of Arkansas, Florida, Kansas, and Virginia and the countries of Belgium, France, India, Italy, Netherlands, Spain, Singapore, and Taiwan. |
| 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 |