Recall Z-0971-2015 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
| Date | Jan 14, 2015 (initiated Dec 3, 2014) |
| Status | Terminated |
| Reason | Artifacts are found in acquired imaging on the SOMATOM Force. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | A customer advisory notice, dated December 3, 2014, was sent to end users that identified the product, problem, and action to be taken. Customers were informed that new software would be installed via remote access. |
| Quantity | 7 |
| Distribution | PA, MA, MN, SC, MD, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133589 | SOMATOM FORCE Siemens Medical Solutions USA, Inc., Apr 17, 2014 |