FDA Device recall Z-0019-2016
SOMATOM Definition Edge
- FDA Device
- Class II
- terminated
- Published 2015-10-14
On 2015-10-14 the FDA classified a Class II recall of SOMATOM Definition Edge by Siemens Medical Solutions Usa, citing software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Co….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0019-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-14 |
| Published | 2015-10-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
SOMATOM Definition Edge; 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 bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin
Identifiers
| code_info | Model#' 10590000 with Serial numbers 83277 83281 83021 83004 83014 83276 83279 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0019-2016%22
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