Z-0729-2017Class II

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

Name: Z-0729-2017 Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and...
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. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images... on 2016-03-28. FDA classified it as Class II and gives the reason as "If images are sent without an order in the system, they will be matched with the latest order on the current patient/modality matching potentially resulting in the matching of the report to the incorrect accession...". 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-0729-2017
Classification: Class II
Status: Terminated
Initiated: 2016-03-28
Posted: 2016-12-09
Terminated: 2020-03-20
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 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 images are sent without an order in the system, they will be matched with the latest order on the current patient/modality matching potentially resulting in the matching of the report to the incorrect accession number (but still associated to the correct patient).
Root cause tag: software
FDA root cause: Software design
Action: MERE sent an Urgent Medical Device Recall letter dated July 11, 2016, to all affected customers via email or via certified mail if they did not have an email address for the customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to respond to the notification using the enclosed form and the return addressed envelope. Customers were also instructed to ensure that all users of the product are provided with the notification and if product was further distributed customers need to identify their customers and notify them at once of the product recall. Customers with questions should send an email to [email protected]. For questions regarding this recall call 877-741-5369.
Quantity in commerce: 198 sites potentially have the effected versions
Distribution: Nationwide Distribution
Product codes and lots: Versions: 8.30.0, 8.30.1, 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, and 10.1.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0729-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0729-2017	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)