18

Dec

2013

Cl II Omnyx Digital Pathology System Software

0

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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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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