FDA-Device2016-02-10Class II
DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
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.
Sold states
US: Nationwide Distribution in the states of FL, OH, and MO.
Affected count
3
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0745-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief