Recall Z-0742-2017 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
SOMATOM Definition AS System, x-ray, tomography, computed 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 15, 2016 |
| Status | Terminated |
| Reason | Software update that provides software and firmware bug-fixes to improve system performance |
| Root cause | Software Design Change |
| Action | Siemens mailed a Customer Information Letter to affected customers on November 21, 2016 informing them of software updates that would provide bug-fixes to improve system performance and stability for customers with SOMATOM Definition AS, Definition Edge and Definition Flash systems using Software versions VA48A_SP1 and VA48A_SP2. The update will remotely be pushed to their systems or customers will be contacted by one of Siemens service organization to arrange a date for installation of the update on site. Customers with questions were instructed to call 1-800-888-7436. |
| Quantity | 104 systems |
| Distribution | Nationwide Distribution |
| 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 |