Z-2871-2016Class II

CADstream software

Name: Z-2871-2016 CADstream software
Creator: Merge Healthcare, Inc.
Published: 2012-11-01
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2012-11-01 / Terminated / root cause: labeling and UDI

FDA source

Merge Healthcare, Inc. began a recall of CADstream software. Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic... on 2012-11-01. FDA classified it as Class II and gives the reason as "An incorrect biopsy or missed target could result if the incorrect grid is selected within the application". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2871-2016
Classification: Class II
Status: Terminated
Initiated: 2012-11-01
Posted: 2016-09-22
Terminated: 2020-10-05
Recalling firm: Merge Healthcare Incorporated
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.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: An incorrect biopsy or missed target could result if the incorrect grid is selected within the application.
Root cause tag: labeling and UDI
FDA 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 [email protected].
Quantity in commerce: 1,349 sites potentially have the affected versions
Distribution: US Nationwide Distribution
Product codes and lots: All versions - Versions 4.1.3 and prior versions

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2871-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2871-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-22

Product code LLZ

K092954Class IICadstream Version 5Confirma, Inc. / cleared 2009-11-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)