Recall Z-0469-2014— Omnyx Llc

Class II FDA medical device recall by Omnyx Llc, initiated 2013-10-01, terminated 2014-04-16. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..

Recalling firm

Omnyx Llc

Classification

Class II

Status

Terminated

Initiated

2013-10-01

Terminated

2014-04-16

Firm location

Pittsburgh, PA, United States

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