Device product
Mammomat Inspiration with Tomosynthesis functionality
Z-0888-2016
Product summary
- Event
- Event 73307
- Status
- Terminated
- Classification
- Class II
- Quantity
- 76 units
- Official record key
device-enforcement:Z-0888-2016
Official wording
Reason: 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
Code information: Model number: 10140000
Distribution pattern: 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.
Derived failure modes
-
Unknown
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