Device Recall Mevatron KD2

Device Model Number 8515520 Serial numbers: 3009 2958 2863 2972 2646 3079 2516 2962 3055 1452 2702 2125 3066 2689 2228 2564 2507 1904 3075 2375 3013 3068 2596 3025 3049 2965 2045 3084 2855 2906 2292 2384 2067 2818 3089

Radiology Devices

2

No

Nationwide Distribution

MEVATRON KD-2, accelerator, Linear, Medical || The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer

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

Radiology Devices

2

No

Worldwide:USA including states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virgina, Wisconsin, and Wyoming and FOREIGN COUNTRIES: Canada, Mexico, Serbia Montenegro, Angola, Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Herzeg-Bosnia, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, DPR of Korea, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Malaysia, Morocco, Nepal, Netherlands, New Zealand, Norway, P.R. China, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uzbekistan, Venezuela, Vietnam, and Zambia

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

MODEL NUMBERS: 8515520, 9822685: Serial Numbers:  1633,  1772,  1874,  1901,  1938,  1941,  1944,  1987,  2014,  2076,  2082,  2088,  2135,  2154,  2173,  2175,  2179,  2228,  2246,  2273,  2315,  2329,  2348,  2383,  2508,  2562,  2568,  2579,  2586,  2598,  2614,  2634,  2645,  2646,  2656,  2676,  2679,  2713,  2743,  2756,  2202,  2462,  2436,  2472,  2474,  2652,  2133,  2224,  2319,  2099,  4,  5,  1894,  1928,  1948,  2043,  2074,  2128,  2131,  2376,  2431,  2437,  2441,  2444,  2496,  2584,  2595,  2687,  2711,  2721,  2757,  2774,  2558,  2726,  2111,  2115,  2457,  2714,  2065,  2413,  2414,  2542,  2577,  2585,  2606,  2623,  2631,  2724,  2725,  2727,  2732,  2739,  2775,  2786,  2824,  2826,  2858,  2859,  2864,  2481,  2563,  2609,  2617,  2638,  2639,  2643,  2649,  2659,  2672,  2697,  2734,  2742,  2771,  2811,  2837,  2885,  2561,  2715,  2718,  02587A,  02592A,  2498,  2621,  2537,  2601,  2422,  2483,  2541,  2624,  2123,  2282,  2327,  2405,  2405,  1953,  2662,  2479,  2569,  2127,  2345,  2754

Radiology Devices

2

No

Worldwide:USA including states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virgina, Wisconsin, and Wyoming and FOREIGN COUNTRIES: Canada, Mexico, Serbia Montenegro, Angola, Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Herzeg-Bosnia, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, DPR of Korea, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Malaysia, Morocco, Nepal, Netherlands, New Zealand, Norway, P.R. China, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uzbekistan, Venezuela, Vietnam, and Zambia

MEVATRON KD-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), MODEL NUMBERS: 8515520 and 9822685, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520

Serial Numbers: 2568 2698 2589 2038 2448 2547 2681 2686 2781 2592 and 2726

Radiology Devices

2

No

Worldwide-USA including states of AL, AK, AZ, AR, CA, CO, DE, DC, FL, GA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MS, MO, MN, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, WV, WI, and WY and countries of Angola, Australia, Austria,Belgium,Brazil,Canada,Chile,Colombia,Costa Rica, Croatia,Cyprus,The Czech Republic,Denmark,DPR of Korea,El Salvador,France,Germany,Greece,Hungary,India,Iran,Ireland,Italy,Japan,Jordan,Malaysia,Mexico, The Netherlands,New Zealand,Norway,P.R. China,Pakistan,Peru,Philippines,Poland,Portugal,Republic of Korea,Romania,Russian Fed.Saudi Arabia,Singapore,Slovakia,South Africa,Spain,Sweden,Taiwan,Thailand,Trinidad,Tobago,Turkey, U.A.E.,Ukraine, The United Kingdom, and Venezuela

Mevatron KD2 Medical Linear Accelerator, Material Number: 01940753, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA

Serial Numbers: 2579 2756 2175 2645 2743 2614 2646 1938 2652 and 2376

Radiology Devices

2

No

Worldwide-USA including states of AL, AK, AZ, AR, CA, CO, DE, DC, FL, GA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MS, MO, MN, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, WV, WI, and WY and countries of Angola, Australia, Austria,Belgium,Brazil,Canada,Chile,Colombia,Costa Rica, Croatia,Cyprus,The Czech Republic,Denmark,DPR of Korea,El Salvador,France,Germany,Greece,Hungary,India,Iran,Ireland,Italy,Japan,Jordan,Malaysia,Mexico, The Netherlands,New Zealand,Norway,P.R. China,Pakistan,Peru,Philippines,Poland,Portugal,Republic of Korea,Romania,Russian Fed.Saudi Arabia,Singapore,Slovakia,South Africa,Spain,Sweden,Taiwan,Thailand,Trinidad,Tobago,Turkey, U.A.E.,Ukraine, The United Kingdom, and Venezuela

Mevatron KD-2 Medical Linear Accelerator, Material Number: 8515520, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA