Recall Z-0320-2009 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
Somatom Sensation 40 X-Ray System, Model number 8874427. This is a computed tomography x-ray system which is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
| Date | Jan 5, 2009 (initiated Sep 3, 2008) |
| Status | Terminated |
| Reason | software error - does not allow protocol to properly synchronize with ECG triggers |
| Root cause | Software design |
| Action | The recalling firm issued a Customer Safety Advisory Notice dated 9/3/08 to affected customers via Update Instructions CT045/08/S. This letter informs customers of the potential issued and provides instruction to avoid its occurrence. For additional information, contact Siemens Medical Solutions USA, Inc. at 1-610-448-4500. |
| Quantity | 168 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040665 | SOMATOM SENSATION 64 AND SENSATION CARDIAC Siemens Medical Solutions USA, Inc., Apr 2, 2004 |