Recall Z-1638-2014 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Siemens Medical Solutions USA, Inc
MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.
| Date | May 20, 2014 (initiated Apr 25, 2014) |
| Status | Terminated |
| Reason | There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an unstable monitor to fall causing possible serious injury. |
| Root cause | Device Design |
| Action | A safety advisory notice, dated April 25, 2014, was sent to direct accounts to notify them of the issue and provide instructions to avoid the potential risk of injury. |
| Quantity | 5 |
| Distribution | Distributed in the states of GA, FL, NY, NV, and MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122286 | MAMMOMAL INSPIRATION Siemens Medical Solutions USA, Inc., Feb 22, 2013 |