Recall – Safety issue identified with cath lab software

Company: Merge Healthcare, Inc.
Date of Enforcement Report: 9/8/2021
Class II

PRODUCT

Merge Hemo, Software packages 10.2, 10.3, and 10.4

Recall Number: Z-2387-2021

REASON

The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface.

RECALLING FIRM/MANUFACTURER

Merge Healthcare, Inc. on 7/23/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

326 units

DISTRIBUTION

U.S. Nationwide

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

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