Proteus 235 Proton Therapy System for cancer treatment.
FDA device recall Z-0020-2015 · posted 2014-10-29 · Terminated
Recall details
- Recalling firm
- Ion Beam Applications S.A.
- 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.
- Action taken
- A User Notice was sent to direct accounts in/about March/April 2014 to notify them of the issue and provide instructions to avoid the identified potential risk to patients.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 8
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of PA, NJ, IL, WA, and TN, and the countries of Germany, Italy, and Czech Republic.
- Date initiated
- 2014-03-27
- Date posted
- 2014-10-29
- Date terminated
- 2014-12-10
- Location
- Louvain La Neuve, Belgium
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IBA PROTON THERAPY SYSTEM- PROTEUS 235 (K082416) | Ion Beam Applications S.A. | 2008-12-12 |