Pinnacle3 Software Version 10.0 recall: Software Issue
Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professionals to enter…
Why was Pinnacle3 Software Version 10.0 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
"System Code S/N" 1439NML05A, 1117FMM025, DC090775040, 1117FMM03J.
- Product
- Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professionals to enter…
- Recalling firm
- Philips Medical Systems, Inc.
- Quantity
- 4
- Distribution
- US Nationwide Distribution in the states of MO, FL, OH
- Recall date
- May 27, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)