Siemens Medical Solutions USA, Inc Siemens Mevatron KD2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number:08515520, Siemens Medical Solutions, Concord, CA 94520 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Siemens Mevatron KD2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number:08515520, Siemens Medical Solutions, Concord, CA 94520
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Serial Numbers: 1938, 1944, 1987, 2082, 2088, 2154, 2173, 2175, 2228, 2246, 2315, 2348, 1894, 1948, 1953, 2043, 2074, 2099, 2131, 2202, 2224, 2282, 2319, 2376, 2405, 2431, 2436, 2437, 2413, 2414, 1633, 1772, 1874, 1901, 1928, 1941, 1985, 2014, 2065, 2076, 2111, 2115, 2123, 2127, 2135, 2145, 2179, 2213, 2216, 2218, 2273, 2297, 2329, 2345, and 2383
Products Sold
Serial Numbers: 1938, 1944, 1987, 2082, 2088, 2154, 2173, 2175, 2228, 2246, 2315, 2348, 1894, 1948, 1953, 2043, 2074, 2099, 2131, 2202, 2224, 2282, 2319, 2376, 2405, 2431, 2436, 2437, 2413, 2414, 1633, 1772, 1874, 1901, 1928, 1941, 1985, 2014, 2065, 2076, 2111, 2115, 2123, 2127, 2135, 2145, 2179, 2213, 2216, 2218, 2273, 2297, 2329, 2345, and 2383
Siemens Medical Solutions USA, Inc is recalling Siemens Mevatron KD2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Pos due to Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial numbers less than 3094, as they do not contain redundant sensors for jaw position.
Recommended Action
Per FDA guidance
The firm has sent consignees a Customer Safety Advisory Notice on August 7, 2007 informing them that a misplacement of the X and/or Y jaws can occur if interlock #51 Jaw Field Position is asserted and then cleared with the left-hand key rest. The firm recommends that if an interlock issue is encountered tha treatment of the patient be discontined until this issue is resolved.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026