FDA Device recall Z-0020-2016
SOMATOM Definition Flash
- FDA Device
- Class II
- terminated
- Published 2015-10-14
On 2015-10-14 the FDA classified a Class II recall of SOMATOM Definition Flash 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-0020-2016 |
| 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 Flash; 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# 10430603 with Serial numbers 73476 73586 73544 73648 73636 73621 73533 73423 73424 73520 73493 734…Model# 10430603 with Serial numbers 73476 73586 73544 73648 73636 73621 73533 73423 73424 73520 73493 73459 74191 73487 73492 73494 73497 73013 73657 73535 73667 73490 73513 74192 73697 73635 73471 73405 73600 73558 73591 73546 73478 73504 73413 73674 73445 73547 73420 73430 |
|---|
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-0020-2016%22
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