Z-0685-2008

Siemens Mevatron K-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position)...

Name: Z-0685-2008 Siemens Mevatron K-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position)...
Creator: Siemens Medical Solutions USA, Inc
Published: 2007-08-07
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2007-08-07 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Mevatron K-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 1940753, Siemens Medical Solutions... on 2007-08-07. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0685-2008
Status: Terminated
Initiated: 2007-08-07
Posted: 2008-02-14
Terminated: 2010-12-01
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
Product code: IYE Accelerator, Linear, Medical
Reason for recall: 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 tag: design
FDA 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 in commerce: 59 units
Distribution: Worldwide Distribution
Product codes and lots: 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

Product code IYE

K862339Class IIMevatron Kd-2Siemens Medical Laboratories, Inc. / cleared 1986-10-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)