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