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Omnyx Llc recalls Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which consists of
Recalled December 18, 2013 · FDA recall Z-0469-2014 · Omnyx
Hazard
There is an issue associated with Digital Pathology System (DPS) Software, in which the annotation tools within the DPS version 1.1 Image Viewer will display incorrect measurements and area calculations for a region of interest on a scanned slide, under certain conditions. · FDA Class II
Units
2
Sold at
International Distribution to Canada and Switzerland only.
Description
There is an issue associated with Digital Pathology System (DPS) Software, in which the annotation tools within the DPS version 1.1 Image Viewer will display incorrect measurements and area calculations for a region of interest on a scanned slide, under certain conditions.
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 digital whole slide images. Omnyx" products are for in vitro diagnostic use for specific clinical applications, and are intended for research use only on other applications. Specific clinical use applications are indicated in separate clinical specific user guides supplied by Omnyx.
Manufacturer(s)
Omnyx Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →