FDA Device recall Z-0744-2017
SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstructi…
- FDA Device
- Class II
- terminated
- Published 2016-12-21
On 2016-12-21 the FDA classified a Class II recall of SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstructi… by Siemens Medical Solutions Usa, citing software update that provides software and firmware bug-fixes to improve system performance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0744-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-15 |
| Published | 2016-12-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
SOMATOM Definition Edge 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
Reason
Software update that provides software and firmware bug-fixes to improve system performance
Identifiers
| code_info | Model # 10590000 Serial Numbers: 65127 95798 73739 83277 66219 65491 65453 95738 96357 65615 73726 66467 6…Model # 10590000 Serial Numbers: 65127 95798 73739 83277 66219 65491 65453 95738 96357 65615 73726 66467 64860 73860 65712 65304 65437 65614 65856 96305 73296 73831 83403 73840 64709 96335 73673 65639 95003 65501 96351 73778 96028 96316 83520 96288 66396 96238 96352 96324 96336 65480 96312 95768 73777 95955 73883 83399 73783 96226 96303 96047 65609 73791 73887 73071 96266 95701 74368 83537 73895 96214 95925 96347 96061 83533 74226 74297 65760 74376 65017 65516 73162 64065 65455 83524 66041 65618 73818 66066 73028 83306 65680 65734 73905 95797 65672 73886 96302 83398 73538 95717 96053 65972 95278 96326 96327 96286 95447 74200 74289 96364 95510 64140 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0744-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.