Z-1496-2017Class II

Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare...

Name: Z-1496-2017 Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare...
Creator: Merge Healthcare, Inc.
Published: 2015-09-22
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2015-09-22 / Terminated / root cause: manufacturing process

FDA source

Merge Healthcare, Inc. began a recall of Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI on 2015-09-22. FDA classified it as Class II and gives the reason as "For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they are for the same patient if they all have the first name...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1496-2017
Classification: Class II
Status: Terminated
Initiated: 2015-09-22
Posted: 2017-03-20
Terminated: 2017-04-18
Recalling firm: Merge Healthcare Incorporated
Product: Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they are for the same patient if they all have the first name, last name, and medical record number in common.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Merge sent an Urgent: Medical Device Recall letter dated March 28, 2016, via email the week of April 4, 2016, or via certified mail if they did not have an email address for the customer. On/about September 22, 2015, the recalling firm emailed "IMPORTANT PRODUCT INFORMATION" letters dated August 20, 2015, to their customers. The letter notifies the customer of the issue and informs them a fix for the issue is in the new software release. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. The response form asks, in part, if they are interested in accepting the fix. If they decline the fix, they are asked to provide the reason why. The response was required no later than April 18, 2016. Nonresponders were issued a second letter dated July 11, 2016, asking for a response by August 2, 2016. The letter and response form contained the same information as the first letter. If the second letter results in additional unresponsive customers, a call campaign will be managed by Customer Support and documented via SalesForce. The recalling firm reported emails will be tracked for delivery confirmation and the letters will be tracked for delivery by USPS certified services. For further questions, please call (877) 741-5369. .
Quantity in commerce: 16 sites were originally identified as potentially having the affected versions
Distribution: US Distribution was made to medical facilities located in GA, IL, MD, MI, MO, OH, TN, and VT. There was no foreign/government/military distribution.
Product codes and lots: Versions 8.30, 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, 10.0, 10.0.1, and 10.1 with Issuer of Patient ID (IPID)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1496-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1496-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-20

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)