FDA Device

Proteus 235, Proton Therapy System

Hazard

In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.

What You Should Do

Remedy

A Field Safety Notice was mailed to the customer affected by the issue on 03/21/2017. The Notice informed the user when resuming from a partial irradiation, to ensure that the correct delivered dose has been selected in the partial report dialog box before proceeding with irradiation.

Products

Proteus 235, Proton Therapy System
UPC
Serial Number: SAT.123 (US), and SBF.101 (EU). Versions PTS-9.3.1.2 and PTS-9.4.0

Units Affected

2 worldwide, 1 in U.S.