Reported May 27, 2015 · Terminated
Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified…
Philips Medical Systems, Inc.
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, Inc. · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
Pinnacle3 Software Version 10.0Model 459800200841
- Product UsageThe Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to construct a plan for radiation therapy and evaluate the plan. Optionally, the qualified medical personnel may output the plan in an electronic or printed form for use by other systems in the delivery of treatment to a patient
- Lot codes and dates
"System Code S/N" 1439NML05A1117FMM025DC0907750401117FMM03J
- Amount recalled
- 4
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
A problem (the dose computed in planning mode is calculated incorrectly ) has been detected in the Philips Pinnacle3 software version 10.0 that, if it were to re-occur, could pose a risk for patients or users. Specifically, the dose engine is being passed the wrong snout position. The snout position is used to determine the penumbra of the beam which includes the calculation of the source si
This product could cause temporary or reversible health problems — stop using it.
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