FDA-Device2016-03-02Class II
Mammomat Inspiration with Tomosynthesis functionality
Siemens Medical Solutions USA, Inc
Hazard
A potential system fatal error may occur during tomosynthesis reconstruction with large breasts that cover nearly the entire detector surface and with a breast thickness larger than 90 mm. The data to be processed for the tomosynthesis application can exceed the capacity of the graphical processing unit (GPU). If the fatal error message occurs, reconstruction of the data will be aborted. The syste
Sold states
Nationwide Distribution including Puerto Rico and to the states of : AR, CA, CO, FL, GA, IA, IL, IN, KS, MA, MD, MI, MO, NC, NE, NH, NJ, NY, OH, PA, SC, TN, TX, VA and WI.
Affected count
76 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Mammomat Inspiration with Tomosynthesis functionality
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0888-2016Don't want to check this manually?
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