Z-2709-2016Class II

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

Name: Z-2709-2016 Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system
Creator: Merge Healthcare, Inc.
Published: 2016-02-09
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2016-02-09 / 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. Image processing system on 2016-02-09. FDA classified it as Class II and gives the reason as "A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR)". 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-2709-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-09
Posted: 2016-09-01
Terminated: 2017-08-24
Recalling firm: Merge Healthcare Incorporated
Product: Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR).
Root cause tag: software
FDA root cause: Software design
Action: MERGE sent an Urgent Medical Device Recall letter dated February 9, 2016, to all affected customers via email or via certified mail if they did not have an e-mail address for 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. For further questions, please call (800) 724-5970 ext. 8027.
Quantity in commerce: 116 customers potentially have the affected versions
Distribution: Nationwide Distribution
Product codes and lots: Versions 10.1 and 10.1.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2709-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2709-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-09-01

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)