Siemens Mevatron M-2 6740 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position)Model Number: 9401506, Siemens Medical Solutions, Concord, CA 94520
FDA Recall Z-0679-2008 · Posted 2008-02-14
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2007-08-07
Date Terminated2010-12-01
Product Quantity29 units
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.