Software version VD10E for Syngo X-Workplace — Class II medical device recall Z-0597-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-01-13, distributed nationwide. Potential post-processing software issue when using tabcard "4D" on X-Workplace with software version VD10E. A
| Recall number | Z-0597-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2015-11-18 |
| Classified | 2016-01-06 |
| Reported by FDA | 2016-01-13 |
| Terminated | 2016-12-05 |
| Distributed | Nationwide (US) |
| Quantity | 73 units |
| Reason classes | software |
Product
Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0597-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.