The Recall Desk
ModerateFDA (Devices)·Z-0469-2014·Announced 2013-12-18

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.

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, 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 dig
Manufacturer
Omnyx Llc
Category
Medical Device — Digital Pathology Software
Hazard
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.

Related recalls

Same hazard · incorrect measurement

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