FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Seimens Mevatron KD-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 9822685, Siemens Medical Solutions, Concord, CA 94520
- Recall number
- Z-0681-2008
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Seimens Mevatron KD-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 9822685, Siemens Medical Solutions, Concord, CA 94520
- Status
- Terminated
- Initiated
- 2007-08-07
- Posted
- 2008-02-14
- Terminated
- 2010-12-01
- Reason
- 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.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 55 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- 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, 2383
- 510(k) numbers
- ["K862339"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2937457
- Firm city
- Concord
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28