FDA Device recall Z-0597-2016
Software version VD10E for Syngo X-Workplace
- FDA Device
- Class II
- terminated
- Published 2016-01-13
On 2016-01-13 the FDA classified a Class II recall of Software version VD10E for Syngo X-Workplace by Siemens Medical Solutions Usa, citing potential post-processing software issue when using tabcard "4D" on X-Workplace with software version VD10E. A too small measurement in the MPRs of a volume when images are acquir….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0597-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-18 |
| Published | 2016-01-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.
Reason
Potential post-processing software issue when using tabcard "4D" on X-Workplace with software version VD10E. A too small measurement in the MPRs of a volume when images are acquired with a CT scanner with a tilted gantry. In a 2x2 layout, the 4D tabcard will show an incorrect, too small length measurement. This could result in selecting a device of the wrong size, which then needs to be exchanged.
Identifiers
| code_info | Software Version: SW VD-10E |
|---|
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-0597-2016%22
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