Date Initiated by Firm | February 11, 2013 |
Date Posted | February 20, 2013 |
Recall Status1 |
Terminated 3 on January 21, 2014 |
Recall Number | Z-0841-2013 |
Recall Event ID |
64328 |
510(K)Number | K110730 |
Product Classification |
System, planning, radiation therapy treatment - Product Code MUJ
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Product | Monaco RTP System.
Radiation treatment planning. |
Code Information |
Versions 3.20.00 and 3.20.01 |
Recalling Firm/ Manufacturer |
Elekta, Inc. 400 Perimeter Center Ter Ne Ste 50 Atlanta GA 30346-1227
|
For Additional Information Contact | Chris Ivicevich 408-830-8023 |
Manufacturer Reason for Recall | The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Elekta provided customers with an "Important Safety Notice - Dose Display Not Matching Beam Geometry - Monaco RFC 35748". The notice identified the product, problem, and actions to be taken by the customers. Contact the form at 800-878-4267 for questions relating to this notice. |
Quantity in Commerce | 13 |
Distribution | Nationwide Distribution-including the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = MUJ
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