This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
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