Recall Z-0523-2012 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Siemens Medical Solutions USA, Inc
MAMMOMAT Inspiration Full field digital mammographic x-ray system
| Date | Jan 11, 2012 (initiated Sep 15, 2011) |
| Status | Terminated |
| Reason | Lowering the swivel arm with "object table" while an operator's or patient's body parts are underneath the "object table" may cause the "object table" to collide with and injure the operator or patient. Therefore attention should be paid when adjusting "object table" height to avoid a possible risk of injury to the operator or the patient. The movement of the swivel arm may also cause an injur |
| Root cause | Use error |
| Action | Siemens Medical Solutions USA, Inc sent a Safety Advisory Notice dated January 8, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The notification included an Addendum to the User Manual. We appreciate your understanding and cooperation with this safety advisory and ask you to immediately instruct your operating personnel accordingly. Please ensure that this safety advisory is placed in the System's Operator Manual. Your operating personnel should maintain awareness over an appropriate defined period. Furt |
| Quantity | 12 |
| Distribution | Nationwide Distribution including the states of FL, MD, MI, NE, NY, NC, ND, OH, and SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.