Z-0399-2017Class II

Merge LIS software

Name: Z-0399-2017 Merge LIS software
Creator: Merge Healthcare, Inc.
Published: 2015-03-05
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2015-03-05 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge LIS software on 2015-03-05. FDA classified it as Class II and gives the reason as "There is a potential for duplicate container numbers to be created for patients". 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-0399-2017
Classification: Class II
Status: Terminated
Initiated: 2015-03-05
Posted: 2016-11-11
Terminated: 2019-04-12
Recalling firm: Merge Healthcare Incorporated
Product: Merge LIS software.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: There is a potential for duplicate container numbers to be created for patients.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm issued a letter dated 1/27/2016 via e-mail on 1/30/2016. If no email address was available, the letters were issued via certified mail. Letters to nonresponders were issued 5/26/2016.
Quantity in commerce: 413 sites potentially have the affected software
Distribution: Distribution was made nationwide and to the Virgin Islands. Foreign distribution was made to the Bahamas.
Product codes and lots: Versions: 4.0.1 and earlier.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0399-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0399-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-11

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)