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Terminated

Proteus 235 Proton Therapy System for cancer treatment.

FDA Recall Z-0020-2015 · Posted 2014-10-29

Recalling FirmIon Beam Applications S.A.
Recall StatusTerminated
Product CodeIYE
Date Initiated2014-03-27
Date Terminated2014-12-10
Product Quantity8

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.

Firm Action

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

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082416IBA PROTON THERAPY SYSTEM- PROTEUS 235Ion Beam Applications S.A. · 2008-12-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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