Home / Recalls / Medical Devices
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
Recalled February 10, 2016 · FDA recall Z-0745-2016 · Philips Medical Systems
Hazard
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. · FDA Class II
Units
3
Sold at
US: Nationwide Distribution in the states of FL, OH, and MO.
Description
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.
Product
DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
Manufacturer(s)
Philips Medical Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →