Proteus 235 Proton Therapy System for cancer treatment.
Reported: November 5, 2014 Initiated: March 27, 2014 #Z-0020-2015
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.
Details
- Recalling Firm
- Ion Beam Applications S.A.
- Units 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.
- Location
- Louvain La Neuve, N/A
Frequently Asked Questions
What product was recalled? ▼
Proteus 235 Proton Therapy System for cancer treatment.. Recalled by Ion Beam Applications S.A.. Units affected: 8.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 5, 2014. Severity: Moderate. Recall number: Z-0020-2015.
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