Recall Z-0888-2016— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2016-02-12, terminated 2017-11-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Mammomat Inspiration with Tomosynthesis functionality. 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.
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-12
- Terminated
- 2017-11-08
- Firm location
- Malvern, PA, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.