Z-0118-2017Class II

CADstream software

Name: Z-0118-2017 CADstream software
Creator: Merge Healthcare, Inc.
Published: 2011-10-19
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2011-10-19 / Terminated / root cause: software

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 2011-10-19. FDA classified it as Class II and gives the reason as "Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient follow-up". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0118-2017
Classification: Class II
Status: Terminated
Initiated: 2011-10-19
Posted: 2016-10-18
Terminated: 2020-09-18
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: Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient follow-up.
Root cause tag: software
FDA root cause: Software design
Action: Merge sent an Urgent Medical Device Recall dated January 28, 2016 to affected customers via email and certified mail if no email address was available. The letter identified the affected product, problem and actions to be taken. For questions Customer Service at 877-741-5369 or [email protected].
Quantity in commerce: 844 sites potentially have the affected versions
Distribution: US Nationwide Distribution
Product codes and lots: Versions prior to 5.2.6

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0118-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0118-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-18

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)