Recall Z-0086-2015 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Siemens Medical Solutions USA, Inc
Siemens Mammomat Inspiration mammography systems. 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 | Oct 17, 2014 (initiated Sep 18, 2014) |
| Status | Terminated |
| Reason | The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. The pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. The needle positioning device may move even with the safety switch being set sideward. If this occurs with the needle being already i |
| Root cause | Process control |
| Action | A safety advisory notice, dated September 18, 2014, was sent to end users that identified the product, problem, and actions to be taken. |
| Quantity | 3 |
| Distribution | US Distribution in states of: NY, VA, 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 |