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Recall Observatory FDA recall evidence

Device product

MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #09401746 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13

Z-1678-2020

February 18, 2020

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 85161
Status
Terminated
Classification
Class II
Quantity
1012
Official record key
device-enforcement:Z-1678-2020

Official wording

Reason: Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.

Code information: Serial Numbers 2507, 2516, 2596, 2689, 2818, 2962, 3013, 3103, 3089, 3136, 2855, 3296, 3397, 3591, 3629, 3639, 3644, 3702, 3873, 3939, 4018, 3986, 70-4146, 70-4347, 70-4363, 5092, 5114, 5523, 70-4287, 2045, 2067, 2125

Distribution pattern: Worldwide distribution. US consignees in the following states: Alabama, California, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia, Wyoming

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.