Reported Feb 10, 2016 · Terminated
DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model…
Philips Medical Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
- Lot codes and dates
- Software Version 10.0.0 and 14.0.0
- Amount recalled
- 3
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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