FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens Mevatron K-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 1940753, Siemens Medical Solutions, Concord, CA 94520
- Recall number
- Z-0685-2008
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens Mevatron K-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 1940753, 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
- 59 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- Serial Numbers: 2568, 2698, 2038, 2168, 2448, 2451, 2452, 2459, 2466, 2498, 2505, 2525, 2531, 2547, 2561, 2575, 2589, 2592, 2616, 2648, 2663, 2667, 2681, 2686, 2726, 2729, 2751, 2769, 2777, 2781, 2801, 2807, 1798, 2213, 2216, 2218, 2571, 2582, 2602, 2607, 2612, 2636, 2731, 2877, 2951, 2952, 3021, 3029, 3041, 1985, 2145, 2229, 2297, 2353, 2509, 2601, 2754, 2776, and 2394
- 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
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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