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Class 2 Device Recall Mevatron KDS2 |
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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-0680-2008 |
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 KDS-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number 9822693 and 9411588, Siemens Medical Solutions, Concord, CA 94520 |
Code Information |
Serial Numbers: 2108, 2183, 2244, 2251, 2263, 2272, 2284, 2289, 2335, 2357, 2084, 2168, 2264, 2304, 2394, 2398, 2023, 2055, 2097, 2106, 2122, 2158, 2208, 2222, 2242, 2269, 2276, 2324, 2336, 2339, 2353, 2358, 2372, 2196, 2229 |
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 |
35 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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