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Health product recall

Omnyx Integrated Digital Pathology System (2013-10-02)

Starting date:
October 2, 2013
Posting date:
October 25, 2013
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-36387

Recalled products

 A. Omnyx Integrated Digital Pathology System

Reason

The annotation tools used 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 use conditions.

Affected products

A. Omnyx Integrated Digital Pathology System

Lot or serial number

Not applicable

Model or catalog number
  • OMN-10005072-X
Companies
Manufacturer
Omnyx, LLC
30 Isabella Street, Suite 301,
Pittsburgh
15212
Pennsylvania
UNITED STATES