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

Upcoming Public Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

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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.