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U.S. Department of Health and Human Services

Class 2 Device Recall Mevatron K2

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 Class 2 Device Recall Mevatron K2see related information
Date Initiated by FirmAugust 07, 2007
Date PostedFebruary 14, 2008
Recall Status1 Terminated 3 on December 01, 2010
Recall NumberZ-0685-2008
Recall Event ID 46157
510(K)NumberK862339 
Product Classification Linear Medical Accelerator - Product Code IYE
ProductSiemens 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
For Additional Information Contact
925-246-8407
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.
FDA Determined
Cause 2		Device Design
ActionThe 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 Commerce59 units
DistributionWorldwide Distribution
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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