FDA Device Recall Z-0020-2015: Recall Record

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0020-2015.

Recall Res Number

Z-0020-2015

Recalling Firm / Manufacturer

N/A

FEI Number

3000256071

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2014-03-27

Date Posted

2014-10-29

Date Terminated

2014-12-10

Product Code

IYE

Event Number

68846

Product Quantity

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.

Action Details 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.

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.

Code Information / Serial Numbers PAT.107, PAT.109, PAT.112, PAT.113, PAT.114, PAT.115, PAT.116, PAT.119.

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Medical Device Recall: Z-0020-2015

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer