Date Initiated by Firm |
January 08, 2016 |
Date Posted |
February 02, 2016 |
Recall Status1 |
Terminated 3 on October 05, 2016 |
Recall Number |
Z-0745-2016 |
Recall Event ID |
73023 |
510(K)Number |
K130992
|
Product Classification |
Accelerator, linear, medical - Product Code IYE
|
Product |
DS/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 |
Recalling Firm/ Manufacturer |
Philips Medical Systems 3000 Minuteman Rd Andover MA 01810-1032
|
For Additional Information Contact |
Technical 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 |
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 ). |
Quantity in Commerce |
3 |
Distribution |
US: Nationwide Distribution in the states of FL, OH, and MO. |
Total Product Life Cycle |
TPLC 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) Database |
510(K)s with Product Code = IYE and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
|