Z-1517-2017Class II

Merge Cardio software

Name: Z-1517-2017 Merge Cardio software
Creator: Merge Healthcare, Inc.
Published: 2015-09-22
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2015-09-22 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information... on 2015-09-22. FDA classified it as Class II and gives the reason as "Users can merge a device import file with an image study that already has a confirmed report, which may result in including information not present at the time of physician interpretation". 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-1517-2017
Classification: Class II
Status: Terminated
Initiated: 2015-09-22
Posted: 2017-03-21
Terminated: 2019-08-08
Recalling firm: Merge Healthcare Incorporated
Product: Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Users can merge a device import file with an image study that already has a confirmed report, which may result in including information not present at the time of physician interpretation.
Root cause tag: software
FDA root cause: Software design
Action: On 9/22/2015, the recalling firm issued letters dated 9/8/2015 and flagged "PRODUCT INFORMATION" via email to their customers. The recalling firm also issued letters dated 3/28/2016 via email the week of 4/4/2016. If no email address was available, the letters were issued via certified mail. A letter dated 7/11/2016 was issued to nonresponders.
Quantity in commerce: 89 sites potentially have the affected software
Distribution: US Nationwide Distribution.
Product codes and lots: Versions 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, and 9.0.8

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1517-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1517-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-21

Product code LLZ

K051649Class IIVericis Cardiovascular Image and Information System, Model 4.0Camtronics Medical Systems / cleared 2005-08-02

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)