Z-0289-2021 Class II Terminated

Recalled by Merge Healthcare, Inc. — Hartland, WI

Recall Details

Product Type
Devices
Report Date
November 4, 2020
Initiation Date
January 23, 2017
Termination Date
May 1, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
47 units

Product Description

Merge LIS

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.

Distribution Pattern

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

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