Company: Merge Healthcare, Inc.
Date of Enforcement Report: 7/31/2019
Class II
PRODUCT
Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Recall Number: Z-2062-2019
REASON
Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc. on 7/11/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
179 devices
DISTRIBUTION
Nationwide and Worldwide