FDA Device recall Z-0118-2017
CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting…
- FDA Device
- Class II
- terminated
- Published 2016-10-26
On 2016-10-26 the FDA classified a Class II recall of CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting… by Merge Healthcare, citing customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient follow-up.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0118-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-10-19 |
| Published | 2016-10-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | US |
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
Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient follow-up.
Identifiers
| code_info | Versions prior to 5.2.6 |
|---|
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-0118-2017%22
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