Recall Z-1118-2017 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Siemens Medical Solutions USA, Inc
Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
| Date | Jan 11, 2017 |
| Status | Terminated |
| Reason | Software error |
| Root cause | Software design |
| Action | Siemens mailed a Customer Safety Advisory Notice (CSAN) letter dated January 11, 2017 to affected customers. The letter identified the affected product, the potential risks and the steps to take to avoid the risks associated with the issue. The letter also stated Siemens will release a field modification (software update) to resolve the issue as soon as possible. The new software will be provided to affected customers free of charge. |
| Quantity | 55 units |
| Distribution | United States Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122286 | MAMMOMAL INSPIRATION Siemens Medical Solutions USA, Inc., Feb 22, 2013 |