Z-0161-2008

MEVATRON M-2 6740,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL...

Name: Z-0161-2008 MEVATRON M-2 6740,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL...
Creator: Siemens Medical Solutions USA, Inc
Published: 2007-03-22
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2007-03-22 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of MEVATRON M-2 6740,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401506,MANUFACTURED BY: Siemens Medical... on 2007-03-22. The reason FDA records is "Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0161-2008
Status: Terminated
Initiated: 2007-03-22
Posted: 2007-11-09
Terminated: 2010-12-18
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: MEVATRON M-2 6740,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401506,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode."
Root cause tag: software
FDA root cause: Software design
Action: Distribution of Update Instructions TH007/07/S was sent to all affected sites on March 26, 2007. This was intended to inform users that Service Mode is only for use by authorized personnel, and that unauthorized and/or incorrect softpot parameter changes performed in Service Mode can result in the risk of patient mistreatment. Current control system software versions do not allow unplanned Dosimetry calibration data sets to be erroneously copied during "Service Mode."
Quantity in commerce: 55 units
Distribution: Worldwide:USA including states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virgina, Wisconsin, and Wyoming and FOREIGN COUNTRIES: Canada, Mexico, Serbia Montenegro, Angola, Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Herzeg-Bosnia, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, DPR of Korea, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Malaysia, Morocco, Nepal, Netherlands, New Zealand, Norway, P.R. China, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uzbekistan, Venezuela, Vietnam, and Zambia
Product codes and lots: MODEL NUMBER: 9401506: Serial Numbers: 2011, 2093, 2156, 2161, 2171, 2177, 2186, 2211, 2227, 2247, 2254, 2271, 2325, 2338, 2343, 2349, 2355, 2367, 2369, 2523, 2526, 2758, 2767, 2435, 2591, 2164, 2267, 1969, 2484, 2389, 2301, 2417, 2442, 2581, 2608, 2629, 2632, 2633, 2693, 2741, 2821, 2331, 2723, 2456, 2468, 2533, 2766, 2841, 2889, 2907, 2939, 2943, 2654, 2684, 2503.

Product code IYE

K882729Class IIMevatron, M 2 ClassSiemens Medical Laboratories, Inc. / cleared 1988-09-19

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)