Merge Eye Care PACS Viewer 5.2 Recalled for Incorrect Image Sorting
Merge Healthcare is recalling 18 units of Merge Eye Care PACS Viewer 5.2 due to a software defect that may cause incorrect study indexing and image misidentification.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The specific defect involves data integrity and image misidentification rather than a direct physical hazard like a structural failure or contamination, fitting the Moderate severity criteria for software defects without reported serious injury.
Plain-English summary
Merge Healthcare, Inc. is recalling 18 units of Merge Eye Care PACS Viewer 5.2. This software solution is used for the display, management, and archive of ophthalmic device reports, images, and data. The recall is due to a defect in the software's handling of study image sorting preferences.
The issue occurs when a user has not set specific preferences for the sorting order of study images (such as OS/OD) and reports. In this scenario, the software may assign an incorrect study index. If a user attempts to delete an image, the system may incorrectly read an image as OS (left eye) when it is actually OD (right eye), or vice versa.
The affected units were distributed in Florida, Illinois, Colorado, Michigan, California, New York, North Dakota, Ohio, and Connecticut. Users of this software should contact Merge Healthcare for instructions on how to resolve the issue.
The recalled product
- Product
- Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Care PACS is a software solution using databases for patient demographics, server…
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 18
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 (1)
- Version 5.2
Distribution
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