CADstream software — Class II medical device recall Z-0137-2017
Terminated recall by Merge Healthcare, Inc., reported 2016-10-26, distributed nationwide. The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site st
| Recall number | Z-0137-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2016-01-30 |
| Classified | 2016-10-19 |
| Reported by FDA | 2016-10-26 |
| Terminated | 2020-10-05 |
| Distributed | Nationwide (US) |
| Quantity | 844 sites |
| Reason classes | software |
Product
CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason for recall
The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display. This may result in incorrect patient follow-up.
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-0137-2017. 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.