Merge OrthoPACS Software Recalled for Image Display Ordering Issues
Merge Healthcare is recalling 73 units of Merge OrthoPACS software due to potential display errors in image ordering and scrolling.
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 defect involves software display ordering rather than a direct physical hazard or reported injury, fitting the criteria for moderate severity.
Plain-English summary
Merge Healthcare, Inc. is recalling 73 devices of Merge OrthoPACS software, specifically versions 7.3, 7.3.1, 8.0, and 8.0.1. The recall is due to a potential 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, and New York, as well as internationally to Belgium and Canada. The software provides image manipulation tools for viewing and comparing medical images, including linking, MPR, MIP, and 3D image fusion.
Consumers and healthcare facilities should contact Merge Healthcare for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 73
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)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)
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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