Recall Z-1603-2024 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
| Date | Apr 19, 2024 (initiated Mar 4, 2024) |
| Status | Open, Classified |
| Reason | There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance. |
| Root cause | Device Design |
| Action | On 3/20/2024 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers in person or via email by their customer representative. Customers were instructed to review the notice with their customer representative. Immediate actions taken: IBA carried out an analysis to determine if the impacted sites have some safety parameters checked by the BAPP in their clinical site configuration with values leading to violations. The result of this analysis showed that there are no sites with safety parameters checked by the BAPP out of tolerance. Intermediate action: While waiting for the solution to |
| Quantity | 8 units |
| Distribution | US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA. |
| 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 |