Recall Z-0047-2018 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model 10910500, and Symbia Evo Excel model 10910501 devices.
| Date | Sep 18, 2017 |
| Status | Terminated |
| Reason | The torque wrench used to tighten system bolts during installation was found to be out of tolerance |
| Root cause | Equipment maintenance |
| Action | The recall was initiated via phone and visit beginning 9/18/2017. |
| Quantity | 16 devices |
| Distribution | Distribution was made to medical facilities located in CA, FL, GA, LA, NY, PA, and TN. There was government distribution but no foreign/military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162337 | Symbia 6.5 Siemens Medical Solutions USA, Inc., Sep 8, 2016 |