Company: Omnyx Llc
Date of Enforcement Report:12/18/2013
Class lI:
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.
Recall Number Z-0469-2014
REASON
re 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/MANUFACTURER
Omnyx Llc, Pittsburgh, PA on 10/1//2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2
DISTRIBUTION
International Distribution to Canada and Switzerland only.
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