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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- 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
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 →Related recalls
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