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 Training

Agile Methods for Medical Device and Health IT Software

One day course that expands on the software risk management topics covered in our IEC 62304 and other Emerging Standards for Medical Device and HealthIT Software course. Essentially the same topics are covered but in greater depth with more attention to hands-on analysis of examples.

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) and Italy.