Z-0289-2021Class II

Merge LIS

Name: Z-0289-2021 Merge LIS
Creator: Merge Healthcare, Inc.
Published: 2017-01-23
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2017-01-23 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge LIS on 2017-01-23. FDA classified it as Class II and gives the reason as "A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report". 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-0289-2021
Classification: Class II
Status: Terminated
Initiated: 2017-01-23
Posted: 2020-10-23
Terminated: 2021-05-01
Recalling firm: Merge Healthcare Incorporated
Product: Merge LIS
Product code: NSX
Reason for recall: A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report.
Root cause tag: software
FDA root cause: Software design
Action: A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report.
Quantity in commerce: 47 units
Distribution: Domestic Distribution Only: Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Oklahoma, Tennessee, Texas.
Product codes and lots: Merge LIS versions 4.0.1, 4.1, 4.1.1, 4.1.2, 4.1.3, 4.1.4, 4.1.5, 4.1.5 Patch 1, and 4.1.5 Patch 2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0289-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0289-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-04	2020-10-23

Product code NSX

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)