FDA Device recall Z-2871-2016
CADstream software
- FDA Device
- Class II
- terminated
- Published 2016-09-28
On 2016-09-28 the FDA classified a Class II recall of CADstream software by Merge Healthcare, citing an incorrect biopsy or missed target could result if the incorrect grid is selected within the application.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2871-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-01 |
| Published | 2016-09-28 |
| 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
An incorrect biopsy or missed target could result if the incorrect grid is selected within the application.
Identifiers
| code_info | All versions - Versions 4.1.3 and prior versions |
|---|
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-2871-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.