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