—#43218

Product

Siemens brand PRIMUS Linear Accelerators equipped with the optional Retractable Beam Shield and MEVATRON Linear Accelerator with optinal Retractable Beam Shield.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K993425
Affected lot / code info: 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.

Why it was recalled

Incomplete installation of the optional Beam Shield may allow unexpected doses of radiation outside the radiation protected areas.

Root cause (FDA determination)

Other

Action the firm took

On 1/8/03, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 4040 Nelson Ave, Concord, California 94520-1200

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2003-01-08
Posted by FDA: 2006-01-06
Terminated: 2006-05-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #43218. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.