FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: 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.
- Recall number
- Z-2871-2016
- Recalling firm
- Merge Healthcare, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2012-11-01
- Posted
- not on file
- Terminated
- 2020-10-05
- Reason
- An incorrect biopsy or missed target could result if the incorrect grid is selected within the application.
- Root cause
- Error in labeling
- Action
- Merge sent Urgent Medical Device Recall dated January 28, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions Merge Customer Service at (877) 741-5369 or support@merge.com.
- Quantity
- 1,349 sites potentially have the affected versions
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- All versions - Versions 4.1.3 and prior versions
- 510(k) numbers
- ["K092954"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 1000116130
- Firm city
- Hartland
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28