Z-0730-2017Class II

Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and...

Name: Z-0730-2017 Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and...
Creator: Merge Healthcare, Inc.
Published: 2015-10-01
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2015-10-01 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and... on 2015-10-01. FDA classified it as Class II and gives the reason as "Reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be lost". 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-0730-2017
Classification: Class II
Status: Terminated
Initiated: 2015-10-01
Posted: 2016-12-09
Terminated: 2018-03-23
Recalling firm: Merge Healthcare Incorporated
Product: Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems 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: Reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be lost.
Root cause tag: software
FDA root cause: Software design
Action: MERGE sent an Urgent Medical Device Recall letter dated March 28, 2016, to all affected customers. Non-responders were issued a second letter dated July 11, 2016, The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to reply using the enclosed form and the return addressed envelope and also to ensure that all users of the product were provided with the notification. If product was further distributed, customer were asked to identify their customers and notify them at once of the product recall. Customers with questions were advised to email [email protected]. For questions regarding this recall call 877-741-5369.
Quantity in commerce: 116 sites potentially have the effected versions
Distribution: Nationwide Distribution
Product codes and lots: Versions V10.1 and 10.1.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0730-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0730-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-09

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)