A Picture Archiving and Communication System — Class II medical device recall Z-1349-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-04-13, distributed nationwide. To inform users about the possible incorrect values for Distance Measurements when using certain modalities in
| Recall number | Z-1349-2016 |
|---|---|
| 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 | 2016-01-18 |
| Classified | 2016-04-07 |
| Reported by FDA | 2016-04-13 |
| Terminated | 2017-08-03 |
| Distributed | Nationwide (US) |
| Quantity | 49 imaging |
| Model numbers | 10014063 |
Product
A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
Reason for recall
To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging.
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-1349-2016. 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.