Z-1046-2017Class II

Merge Cardio software

Name: Z-1046-2017 Merge Cardio software
Creator: Merge Healthcare, Inc.
Published: 2016-03-28
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2016-03-28 / 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 2016-03-28. FDA classified it as Class II and gives the reason as "If a reader selects Multi-study review prior to the original study completing its loading process and then immediately returns to image review of the original study, it is possible that not all current images will be...". 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-1046-2017
Classification: Class II
Status: Terminated
Initiated: 2016-03-28
Posted: 2017-01-19
Terminated: 2019-04-08
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: If a reader selects Multi-study review prior to the original study completing its loading process and then immediately returns to image review of the original study, it is possible that not all current images will be present for review, which could result in incorrect treatment/diagnosis.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm issued a letter dated 3/28/2016 via email or via certified mail if they did not have an email address for the customer. A second letter dated 7/11/2016 was issued to nonresponders.
Quantity in commerce: 188 sites potentially have the effected versions
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, 9.0.8, 9.0.9, 10.0, 10.0.1, 10.1, 10.1.1, and 10.1.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1046-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1046-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-18

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)