FDA Device recall Z-0606-2017
SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produc…
- FDA Device
- Class II
- terminated
- Published 2016-11-23
On 2016-11-23 the FDA classified a Class II recall of SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produc… by Siemens Medical Solutions Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0606-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-02 |
| Published | 2016-11-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
SOMATOM Definition AS, 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
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.
Identifiers
| code_info | Model Number: 8098027 Serial Numbers:96020, 96047,74192,83398,96011,83387 96029 |
|---|
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-0606-2017%22
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