PlainRecalls
FDA Devices Moderate Class II Terminated

Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1

Reported: July 31, 2019 Initiated: July 11, 2019 #Z-2063-2019

Product Description

Merge OrthoPACS 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).

Details

Recalling Firm
Merge Healthcare, Inc.
Units Affected
73 devices
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.
Location
Hartland, WI

Frequently Asked Questions

What product was recalled? ▼
Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1. Recalled by Merge Healthcare, Inc.. Units affected: 73 devices.
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 31, 2019. Severity: Moderate. Recall number: Z-2063-2019.

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