FDAFDA · Food and drugs·Recall number Z-0020-2015
Proteus 235 Proton Therapy System for cancer treatment.
Published November 5, 2014 · Recall initiated: March 27, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ion Beam Applications S.A.
- Distributor
- Worldwide Distribution-USA (nationwide) including the states of PA, NJ, IL, WA, and TN, and the countries of Germany, Italy, and Czech Republic.
- Lot
- PAT.107, PAT.109, PAT.112, PAT.113, PAT.114, PAT.115, PAT.116, PAT.119.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Belgium
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.