Z-2865-2016Class II

Merge Cardio software

Name: Z-2865-2016 Merge Cardio software
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 Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications... on 2016-01-30. FDA classified it as Class II and gives the reason as "Patient information in the header is only found on the first page of the report and not on the subsequent pages". 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-2865-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-30
Posted: 2016-09-21
Terminated: 2017-12-15
Recalling firm: Merge Healthcare Incorporated
Product: Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Patient information in the header is only found on the first page of the report and not on the subsequent pages.
Root cause tag: software
FDA root cause: Software design
Action: Merge sent an Urgent Medical Device Recall letter dated January 28, 2016 to affected customers via e-mail or via certified mail if they did not have an e-mail address. The letter identified the affected product, problem and actions to be taken. For questions call Merge Customer Service at (877)741-5369 or [email protected].
Quantity in commerce: 42 sites potentially have the affected version
Distribution: US Nationwide Distribution
Product codes and lots: Version 10.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2865-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2865-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-21

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)