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Class 2 Device Recall Mevatron K2 |
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Date Initiated by Firm |
August 07, 2007 |
Date Posted |
February 14, 2008 |
Recall Status1 |
Terminated 3 on December 01, 2010 |
Recall Number |
Z-0685-2008 |
Recall Event ID |
46157 |
510(K)Number |
K862339
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Product Classification |
Linear Medical Accelerator - Product Code IYE
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Product |
Siemens Mevatron K-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 1940753, Siemens Medical Solutions, Concord, CA 94520 |
Code Information |
Serial Numbers: 2568, 2698, 2038, 2168, 2448, 2451, 2452, 2459, 2466, 2498, 2505, 2525, 2531, 2547, 2561, 2575, 2589, 2592, 2616, 2648, 2663, 2667, 2681, 2686, 2726, 2729, 2751, 2769, 2777, 2781, 2801, 2807, 1798, 2213, 2216, 2218, 2571, 2582, 2602, 2607, 2612, 2636, 2731, 2877, 2951, 2952, 3021, 3029, 3041, 1985, 2145, 2229, 2297, 2353, 2509, 2601, 2754, 2776, and 2394 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 4040 Nelson Ave Concord CA 94520-1200
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For Additional Information Contact |
925-246-8407
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Manufacturer Reason for Recall |
Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial numbers less than 3094, as they do not contain redundant sensors for jaw position.
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FDA Determined Cause 2 |
Device Design |
Action |
The firm has sent consignees a Customer Safety Advisory Notice on August 7, 2007 informing them that a misplacement of the X and/or Y jaws can occur if interlock #51 Jaw Field Position is asserted and then cleared with the left-hand key rest. The firm recommends that if an interlock issue is encountered tha treatment of the patient be discontined until this issue is resolved. |
Quantity in Commerce |
59 units |
Distribution |
Worldwide Distribution |
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 = IYE and Original Applicant = SIEMENS MEDICAL LABORATORIES, INC.
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