Recall Z-0523-2015 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Siemens Medical Solutions USA, Inc
Mammomat Inspiration system: Product Usage: 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 | Dec 6, 2014 (initiated Oct 28, 2014) |
| Status | Terminated |
| Reason | It was determined that if the Mammomat Inspiration system is not secured to the floor (per customer request) and monitors are positioned too far from the table top, there is a potential risk that the Acquisition Workstation (AWS) table may become unstable and fall over. This may result in a serious injury to the operator. |
| Root cause | Use error |
| Action | A safety advisory notice, dated October 28, 2014, was sent to users that identified the product, problem, and actions to be taken to prevent risk to patients and users. Siemens technicians werre instructed to contact customers to schedule a field modification. |
| Quantity | 3 |
| Distribution | US Nationwide Distribution in the state of: WV, NY, and FL.. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122286 | MAMMOMAL INSPIRATION Siemens Medical Solutions USA, Inc., Feb 22, 2013 |