Z-2062-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 31, 2019
- Initiation Date
- July 11, 2019
- Termination Date
- March 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 179 devices
Product Description
Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Reason for Recall
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).
Distribution Pattern
Nationwide distribution to Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Wisconsin. International distribution to Belgium and Canada.
Code Information
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)