Recall Z-2000-2016 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA Inc.
BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: 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 | Jun 15, 2016 (initiated Apr 25, 2016) |
| Status | Terminated |
| Reason | The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service. |
| Root cause | Process design |
| Action | Siemens sent a Customer Safety Advisory Letter to all affected customers. The letter identified the affected product, problem and actions to be taken. Siemens service organization will be contacting customers to schedule the update as per the attached Update Instruction and will be provided the replacement bracket to resolve the issue. For questions contact your Siemens representative. |
| Quantity | 1 unit |
| Distribution | Worldwide Distribution - US Nationwide and the countries of China and Malaysia. |
| 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 |