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U.S. Department of Health and Human Services

Class 2 Device Recall PINNACLE3 RADIATION THERAPY PLANNING SYSTEM

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 Class 2 Device Recall PINNACLE3 RADIATION THERAPY PLANNING SYSTEMsee related information
Date Initiated by FirmJanuary 08, 2016
Date PostedFebruary 02, 2016
Recall Status1 Terminated 3 on October 05, 2016
Recall NumberZ-0745-2016
Recall Event ID 73023
510(K)NumberK130992 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductDS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
Code Information Software Version 10.0.0 and 14.0.0
FEI Number 1218950
Recalling Firm/
Manufacturer		 Philips Medical Systems
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information ContactTechnical Support
800-722-9377
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionPhilips 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 ).
Quantity in Commerce3
DistributionUS: Nationwide Distribution in the states of FL, OH, and MO.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IYE
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