Merge Healthcare, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0289-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Merge LIS

Product Classification:

Class II

Date Initiated: January 23, 2017

Date Posted: November 4, 2020

Recall Number: Z-0289-2021

Event ID: 86449

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.

Status: Terminated

Product Quantity: 47 units

Code Information:

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

Distribution Pattern:

Domestic Distribution Only: Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Oklahoma, Tennessee, Texas.

Voluntary or Mandated:

Voluntary: Firm initiated