Recall Z-0713-2018 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a trained physician as an aid in diagnosis. These CT systems can be used for low dose lung cancer screening in high risk popul
| Date | Oct 2, 2017 |
| Status | Terminated |
| Reason | The table may become unstable if the nuts on the bolts were not adequately tightened and thus have the potential to loosen and several bolts may gradually loosen at the same time. |
| Root cause | Unknown/Undetermined by firm |
| Action | Siemens sent a Customer Safety Advisory Notice letter date October 2, 2017 to their customers. Customers were instructed not to use the table if there is any unusual noise or vibration and to contact Siemens service organization immediately at 1-800-888-7436. Customers were informed that a service technician will schedule an on site repair. |
| Quantity | 6 |
| Distribution | US Nationwide Distribution in the states of FL, MO, NY, TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163296 | SOMATOM go.Up, SOMATOM go.Now Siemens Medical Solutions USA, Inc., Mar 21, 2017 |