Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Published July 31, 2019 · Recall initiated: July 11, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Merge Healthcare, Inc.
- Distributor
- 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.
- Lot
- Version 7.3 (UDI Number (01)00842000100706(10)7.3.0.158618(11)180409); 7.3.1 (UDI Number (01)00842000100706(10)7.3.1.161404(11)180830); 8.0 (UDI Number (01)00842000100775(10)8.0.0.162051(11)181026); 8.0.1 (UDI Number (01)00842000100775(10)8.0.1.165704(11)190528)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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