Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Check against the official notice below — it lists the full affected range.
Merge Healthcare, Inc. has recalled Merge OrthoPACS versions 7.3, 7.3.1, 8.0, and 8.0.1 due to a software issue affecting how prior thumbnail images and mammography scans display. When mammography stacked scrolling is enabled, prior thumbnails may not appear in reverse chronological order and images may not scroll in reverse chronological order, which could affect how radiologists view and compare medical images. A total of 73 devices were affected and distributed nationwide across 30 U.S. states as well as internationally to Belgium and Canada.
The recall notice does not specify what actions affected consumers or healthcare facilities should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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).
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: 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. Quantity: 73 devices Lot/code info: 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)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.