Company: Merge Healthcare, Inc.
Date of Enforcement Report: 9/16/2020
Class II
PRODUCT
Merge PACS
Recall Number: Z-2944-2020
REASON
Measurements done on the Merge PACS generated MPR s may have incorrect measurements.
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc. on 8/6/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
125 total units
DISTRIBUTION
U.S. Nationwide and International