Recall Z-2036-2016 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA Inc.
SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 The Siemens Biograph TruePoint 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 21, 2016 (initiated Apr 22, 2016) |
| Status | Terminated |
| Reason | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. |
| Root cause | Nonconforming Material/Component |
| Action | Siemens sent a Customer Safety Advisory Letter on April 22, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local Siemens representative at the contact numbers provided in the letter. |
| Quantity | 2 units |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141971 | BIOGRAPH TRUE PET/CT FAMILY SOFTWARE Siemens Medical Solutions USA, Inc., Sep 12, 2014 |