Recall Z-0607-2017 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended 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 angles or spiral planes* taken at different angles
| Date | Nov 2, 2016 |
| Status | Terminated |
| Reason | Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version VA48A_SP2 and Care Contrast license correction of potential safety issues. |
| Root cause | Software design |
| Action | Siemens mailed a Customer Safety Notice on November 9, 2016, to customers who were affected by the recall to inform them of a possible malfunction with the systems. The notification explained the underlying issue, the effect if has on the operation of the system, potential risks involved; and the actions they plan to implement to correct the issues. Customers with questions were instructed to call 1-800-888-7436. For questions regarding this recall call 610-448-6471. |
| Quantity | 7 systems |
| Distribution | Nationwide distribution to MI, NY, CA, KY, ND, and NE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152036 | SOMATOM Definition Edge, SOMATOM Definition AS/AS+ Siemens Medical Solutions USA, Inc., Oct 9, 2015 |