Recall Z-1945-2024— Ion Beam Applications S.A.
Class II · Ongoing
Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2024-05-10. It names one FDA 510(k) clearance: K163500. Product: IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.. Reason: Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances.
- Recalling firm
- Ion Beam Applications S.A.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-10
- Firm location
- Ottignies-Louvain-La-Neuve, N/A, Belgium
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Reason for recall
Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
Data sourced from openFDA. This site is unofficial and independent of the FDA.