Recall Z-0809-2015 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA Inc.
Biograph mCT X-4R, System Material Number 10248670. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
| Date | Dec 16, 2014 (initiated Nov 13, 2014) |
| Status | Terminated |
| Reason | Possibility for system display freeze during CT interventional procedures. |
| Root cause | Software design |
| Action | The firm initiated their recall by certified mail on 11/13/2014. |
| Quantity | 8 units total |
| Distribution | Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123737 | BIOGRAPH MCT FAMILY Siemens Medical Solutions USA, Inc., Jan 29, 2013 |