—#66924

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

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K862339
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 4040 Nelson Ave, Concord, California 94520-1200

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2007-08-07
Posted by FDA: 2008-02-14
Terminated: 2010-12-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66924. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.