DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
FDA Recall Z-0745-2016 · Posted 2016-02-02
Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2016-01-08
Date Terminated2016-10-05
Product Quantity3
Reason for Recall
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.
Firm Action
Philips sent an "Urgent Medical Device Correction" letter dated 16-DEC-2015 to affected customers. The letter described the Affected Products, 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
Device Design
Distribution Pattern
US: Nationwide Distribution in the states of FL, OH, and MO.
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.