MEVATRON KD2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 1940753, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520
Hazard
Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode."
What You Should Do
Distribution of Update Instructions TH007/07/S was sent to all affected sites on March 26, 2007. This was intended to inform users that Service Mode is only for use by authorized personnel, and that unauthorized and/or incorrect softpot parameter changes performed in Service Mode can result in the risk of patient mistreatment. Current control system software versions do not allow unplanned Dosimetry calibration data sets to be erroneously copied during "Service Mode."
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Products
- Brand
- Siemens Medical Solutions USA, Inc
- UPC
- MODEL NUMBER: 1940753: Serial numbers 2509, 2568, 2698, 2168, 2459, 2589, 2616, 2667, 1985, 2145, 2213, 2216, 2218, 2297, 2571, 2582, 2602, 2612, 2636, 2776, 2038, 2448, 2451, 2452, 2466, 2505, 2525, 2531, 2547, 2567, 2575, 2578, 2681, 2686, 2751, 2769, 2777, 2781, 2229, 2726, 2111, 2245, 2561, 1798, 2414, 2542, 2585, 2607, 2631, 2724, 2731, 2739, 2824, 2826, 2858, 2859, 2864, 2877, 2951, 2952, 3021, 3029, 3035, 3041, 2394, 2648, 2663, 2801, 2729, 2587, 2592, 02574A, 2498, 2621, 2704, 2494, 2601, 2807, 2327, 2405, 2569, 2353, 2754
Units Affected
83 units