medical Class II Updated 2019-07-31

Merge Healthcare, Inc. recalls Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1

Recalled Product

Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1

Hazard / Issue

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).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Version 7.3 (UDI Number (01)00842000100690(10)7.3.0.158618(11)180409); 7.3.1 (UDI Number (01)00842000100690(10)7.3.1.161404(11)180830); 8.0 (UDI Number (01) 00842000100737 (10) 8.0.0.162051(11)181026); 8.0.1 (UDI Number (01) 00842000100737(10)8.0.1.165704(11)190528)
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