Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The 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.
FDA Recall Z-1643-2015 · Posted 2015-05-21
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Recalling FirmPhilips Medical Systems, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2015-04-23
Date Terminated2016-10-05
Product Quantity4
Reason for Recall
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
Firm Action
Philips Healthcare sent a "Field Safety Notification PROST-T-300-01-06" letter dated 20 April 2015 to their customers. The letter described the Problem Description, Hazard Involved, How to Identify Affected Products, Action to be Taken by Customer / User, Actions Planned by Philips and Further Information and Support (Contact Philips Customer Care Solutions Center at 1-800-722-9377).
Root Cause
Software design
Distribution Pattern
US Nationwide Distribution in the states of MO, FL, OH
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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