Z-0137-2017Class II

CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI

Name: Z-0137-2017 CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI
Creator: Merge Healthcare, Inc.
Published: 2016-01-30
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2016-01-30 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI on 2016-01-30. FDA classified it as Class II and gives the reason as "The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display. This may result in incorrect patient...". 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-0137-2017
Classification: Class II
Status: Terminated
Initiated: 2016-01-30
Posted: 2016-10-19
Terminated: 2020-10-05
Recalling firm: Merge Healthcare Incorporated
Product: CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display. This may result in incorrect patient follow-up.
Root cause tag: software
FDA root cause: Software design
Action: Merge Healthcare Inc. sent an Urgent Medical Device Recall letter dated January 28, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. In addition, the customer is requested to call Customer Service or send them an email to schedule the upgrade. If the customer chooses not to upgrade, they are requested to complete the attached form or go online and complete it. Merge Healthcare is committed to improve efficiencies and enhancing the quality of healthcare worldwide.If you have any additional questions, call Merge Customer Service at (877) 741-5369 or [email protected].
Quantity in commerce: 844 sites potentially have the affected versions
Distribution: Worldwide Distribution - USA (nationwide) Distribution. Foreign/military/government distribution was also made.
Product codes and lots: Versions prior to 5.2.9

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0137-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0137-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-19

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)