Philips Medical Systems recalls DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #4598002…

Recall date

January 8, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0745-2016

FDA classification

Class II

Brand / firm

Philips Medical Systems

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621