Z-1403-2017Class II

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

Name: Z-1403-2017 Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI
Creator: Merge Healthcare, Inc.
Published: 2016-04-04
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2016-04-04 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI on 2016-04-04. FDA classified it as Class II and gives the reason as "When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure". 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-1403-2017
Classification: Class II
Status: Terminated
Initiated: 2016-04-04
Posted: 2017-03-03
Terminated: 2019-07-26
Recalling firm: Merge Healthcare Incorporated
Product: Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure.
Root cause tag: software
FDA root cause: Software design
Action: Merge sent an Urgent : Medical Device Recall letter dated March 28, 2016. If no email address was available, the letters were issued via certified mail. Nonresponders were issued a second letter dated July 11, 2016. For further questions, please call (877) 741-5369.
Quantity in commerce: 110 sites potentially have the affected versions
Distribution: Distribution was made to medical facilities nationwide. There was no foreign/military/government 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, and 10.0.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1403-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1403-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-03

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)