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Terminated

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

FDA Recall Z-0161-2008 · Posted 2007-11-09

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2007-03-22
Date Terminated2010-12-18
Product Quantity55 units

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."

Firm 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."

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K882729MEVATRON, M 2 CLASSSiemens Medical Laboratories, Inc. · 1988-09-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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