The Recall Desk
ModerateFDA (Devices)·Z-2062-2019·Announced 2019-07-31

Merge PACS Software Recalled for Mammography Image Display Errors

Merge Healthcare is recalling specific versions of Merge PACS software because mammography images may not display in the correct reverse chronological order.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a software display error (chronological ordering) with no reported injuries or illnesses, fitting the criteria for a moderate severity issue.

Plain-English summary

Merge Healthcare, Inc. is recalling 179 units of Merge PACS software, specifically versions 7.3, 7.3.1, 8.0, and 8.0.1. The recall was initiated due to a defect where prior thumbnails may not display in reverse chronological order, and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled.

The affected software is distributed nationwide to 30 states, including Arizona, California, Florida, New York, and Texas, as well as internationally to Belgium and Canada. Merge PACS is a medical imaging software that provides tools for viewing and comparing images, including linking, MPR, MIP, 3D image fusion, and measurements.

Healthcare facilities using the affected versions should contact Merge Healthcare for instructions on how to resolve the issue. The defect affects the ordering of image display, which may impact the workflow of reviewing mammography studies.

The recalled product

Product
Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Manufacturer
Merge Healthcare, Inc.
Category
Medical Device — Software
Hazard
Affected units
179

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • 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)

Distribution

Distributed nationwide across the United States.

The notice also names 30 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Merge Healthcare, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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Same manufacturer · Merge Healthcare, Inc.

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