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

Is my product affected?

Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1

• UPC 00842000100690
• UPC 00842000100737

Check against the official notice below — it lists the full affected range.

What happened

Merge Healthcare, Inc. is recalling Merge PACS software versions 7.3, 7.3.1, 8.0, and 8.0.1 due to a problem with how mammography images display when a stacked scrolling feature is enabled. When this feature is turned on, prior thumbnail images may not appear in reverse chronological order, and images may not scroll in reverse chronological order. A total of 179 devices have been distributed nationwide across 30 U.S. states, as well as internationally to Belgium and Canada.

The source does not specify what action affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

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).

Details from the source

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: 179 devices 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)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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