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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens

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  Class 2 Device Recall Siemens see related information
Date Initiated by Firm January 08, 2003
Date Posted January 06, 2006
Recall Status1 Terminated 3 on May 15, 2006
Recall Number Z-0355-06
Recall Event ID 34167
510(K)Number K993425  
Product Classification Accelerator, Linear, Medical - Product Code IYE
Product Siemens brand PRIMUS Linear Accelerators equipped with the optional Retractable Beam Shield and MEVATRON Linear Accelerator with optinal Retractable Beam Shield.

Code Information Serial numbers: 1941, 1944, 1953, 1991, 2014, 2029, 2093, 2111, 2113, 2163, 2182, 2238, 2281, 2295, 2329, 2389, 2407, 2429, 2431, 2435, 2443, 2455, 2471, 2486, 2487, 2489, 2495, 2497, 2504, 2527, 2549, 2553, 2557, 2558, 2572, 2586, 2594, 2603, 2605, 2607, 2635, 2637, 2642, 2653, 2675, 2689, 2699, 2712, 2728, 2731, 2736, 2737, 2744, 2746, 2772, 2793, 2795, 2805, 2809, 2843, 2845, 2853, 2865, 2873, 2879, 2926, 2942, 2946, 2949, 2969, 2972, 2976, 3007, 3138, 3152, 3157, 3167, 3184, 3187, 3196, 3247, 3286, 3325, 3337, 3352, 3379, 3439, 3442, 3463, 3512, 3527, 3528, 3532, 3535, 3538, 3559, 3647, 3648, 3652, 3664, 3674, 2174, 2176, 2178, 2187, 2188, 2209, 2215, 2253, 2259, 2266, 2285, 2296, 2298, 2303, 2308, 2356, 2359, 2365, 2377, 2381, 2386, 2409, 2416.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord CA 94520-1200
Manufacturer Reason
for Recall		 Incomplete installation of the optional Beam Shield may allow unexpected doses of radiation outside the radiation protected areas.
FDA Determined
Cause 2		 Other
Action On 1/8/03, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.
Quantity in Commerce 125 units
Distribution 28 units shipped within the US, 97 shipped internationally, to countries including Japan, India, Taiwan, Hungary, Italy, France, Colombia, Germany, Austria, CAnada, Croatia, Poland, Croatia, Brazil, Turkey, Greece, Egypt, China, South Korea, Malaysia, Herzogovina.
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 = SIEMENS MEDICAL SOLUTIONS USA, INC.
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