CADstream software Product Usage: CADstream is an image processing… — Class II medical device recall Z-0118-2017
Terminated recall by Merge Healthcare, Inc., reported 2016-10-26, distributed nationwide. Customers may experience an issue with the software study preferences when changes are made to the study proto
| Recall number | Z-0118-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2011-10-19 |
| Classified | 2016-10-18 |
| Reported by FDA | 2016-10-26 |
| Terminated | 2020-09-18 |
| Distributed | Nationwide (US) |
| Quantity | 844 sites |
| Reason classes | software |
Product
CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools.
Reason for recall
Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting 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-0118-2017. 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.