Cl II Philips DS/US Proton Feature

Company: Philips Medical Systems
Date of Enforcement Report 2/10/2016
Class lI:

PRODUCT

DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
Recall Number Z-0745-2016

REASON
In DS/US proton planning, there is a correction factor used internally to the dose engine that is calculating improperly in some cases. This can result in an incorrect dose calculation.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA on 1/8/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
3

DISTRIBUTION
US: Nationwide Distribution in the states of FL, OH, and MO.

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