Recall Z-0888-2016 ยท OTE Digital Breast Tomosynthesis
Siemens Medical Solutions USA, Inc
Mammomat Inspiration with Tomosynthesis functionality
| Date | Feb 12, 2016 |
| Status | Terminated |
| 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 |
| Root cause | Software design |
| Action | Siemens sent a Field Safety Notice dated February 11, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. How will the issue finally be resolved? Siemens is releasing a field modification to resolve this issue as soon as possible. The upgrade software (VB30P) will be available to the affected customers free of charge. A Siemens service engineer will contact you to schedule implementation of the modification for your system. According to regulations set forth in 21 CFR 7.49(d), we advise that you follow the inst |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.