Ion Beam Applications S.A.: Medical Device Recall in 2014 - (Recall #: Z-0020-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Proteus 235 Proton Therapy System for cancer treatment.

Product Classification:

Class II

Date Initiated: March 27, 2014

Date Posted: November 5, 2014

Recall Number: Z-0020-2015

Event ID: 68846

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.

Status: Terminated

Product Quantity: 8

Code Information:

PAT.107, PAT.109, PAT.112, PAT.113, PAT.114, PAT.115, PAT.116, PAT.119.

Distribution Pattern:

Worldwide Distribution-USA (nationwide) including the states of PA, NJ, IL, WA, and TN, and the countries of Germany, Italy, and Czech Republic.

Voluntary or Mandated:

Voluntary: Firm initiated