Omnyx Digital Pathology Software Recalled for Incorrect Measurement Display
Omnyx LLC is recalling Digital Pathology System (DPS) Software version 1.1 because its annotation tools may display incorrect measurements and area calculations for regions of interest on scanned slides.
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, and the source text does not report any hospitalizations, injuries, or deaths. The hazard involves incorrect data display rather than a direct physical safety risk, fitting the criteria for a moderate severity recall.
Plain-English summary
Omnyx LLC is recalling Digital Pathology System (DPS) Software version 1.1. The recall involves the Omnyx Integrated Digital Pathology system, which includes a whole slide scanner and associated software applications used for scanning, receiving, storing, managing, annotating, and viewing digital whole slide images. The software is intended for in vitro diagnostic use for specific clinical applications and for research use on other applications.
The recall is due to an issue where the annotation tools within the DPS version 1.1 Image Viewer may display incorrect measurements and area calculations for a region of interest on a scanned slide under certain conditions. This defect could lead to inaccurate data being presented to users during the analysis of digital pathology images.
The affected software was distributed internationally to Canada and Switzerland only. Users of the Omnyx Integrated Digital Pathology system should check their software version and contact Omnyx LLC for further instructions on how to resolve the issue.
The recalled product
- Product
- Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managing, annotating and computer monitor viewing system for…
- Manufacturer
- Omnyx Llc
- Affected units
- 2
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 (3)
- catalog # OMN-1005056-1
- K1600LH
- DPS 1.1
Distribution
Distribution scope not specified by the agency.
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