Recall Z-0020-2015— Ion Beam Applications S.A.
Class II · Terminated
Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2014-03-27, terminated 2014-12-10. It names one FDA 510(k) clearance: K082416. Product: Proteus 235 Proton Therapy System for cancer treatment.. Reason: While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low Level Radio Frequency (LLRF) pulsed dee voltage (i.e., voltage applied between two electrodes in the cyclotron to accelerate protons) may generate a hot spot on a pencil beam position within a tumor, generating a dose that might exceed the prescribed dose on a single voxel..
- Recalling firm
- Ion Beam Applications S.A.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-27
- Terminated
- 2014-12-10
- Firm location
- 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
Proteus 235 Proton Therapy System for cancer treatment.
Reason for recall
While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low Level Radio Frequency (LLRF) pulsed dee voltage (i.e., voltage applied between two electrodes in the cyclotron to accelerate protons) may generate a hot spot on a pencil beam position within a tumor, generating a dose that might exceed the prescribed dose on a single voxel.
Data sourced from openFDA. This site is unofficial and independent of the FDA.