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Recall Observatory FDA recall evidence

Device product

Mammomat Inspiration with Tomosynthesis functionality

Z-0888-2016

February 12, 2016

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
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

    reason.no_named_rule · v1.0.0

    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