FDAFDA · Food and drugs·Recall number Z-1678-2020
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
Published April 15, 2020 · Recall initiated: February 18, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- 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
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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