Mammomat Inspiration with Tomosynthesis functionality
Reported: March 2, 2016 Initiated: February 12, 2016 #Z-0888-2016
Product Description
Mammomat Inspiration with Tomosynthesis functionality
Reason for Recall
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
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 76 units
- Distribution
- 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.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Mammomat Inspiration with Tomosynthesis functionality. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 76 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 2, 2016. Severity: Moderate. Recall number: Z-0888-2016.
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