Recall – Incorrect medications associated with patient in LIS software

Company: Merge Healthcare, Inc.
Date of Enforcement Report: 11/4/2020
Class II

PRODUCT

Merge LIS

Recall Number: Z-0289-2021

REASON

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.

RECALLING FIRM/MANUFACTURER

Merge Healthcare, Inc. on 1/23/2017. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

47 units

DISTRIBUTION

U.S. Nationwide

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.