Class 2 Device Recall Siemens

• Date Initiated by Firm: January 08, 2003
• Date Posted: January 06, 2006
• Recall Status: Terminated 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.
• FEI Number: 2937457
• 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: 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