This page has been archived on the Web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.

Health product recall

OMNYX INTEGRATED DPS SOFTWARE and DYNAMYX SOFTWARE (2016-07-20)

Starting date:
July 20, 2016
Posting date:
July 22, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Healthcare Professionals, General Public, Hospitals
Identification number:
RA-59486

Affected products

  1. OMNYX INTEGRATED DPS SOFTWARE
  2. DYNAMYX SOFTWARE

Reason

Omnyx has determined that there is an issue with the digital archive (DA) management tool when used with DPS 1.3.0, DPS 1.3.1, and Dynamyx 2.0 versions software. When migrating cases to a new DA, the DA management tool may cause images to improperly appear in the unmatched slide tab, and may also change the status of the case from the current status to "awaiting scans."

Affected products

A. OMNYX INTEGRATED DPS SOFTWARE

Lot or serial number

Not Appicable

Model or catalog number

OMN-10005056-X

Companies
Manufacturer

OMNYX, LLC

1251 Waterfront Place

Pittsburgh

15222

Pennsylvania

UNITED STATES


B. DYNAMYX SOFTWARE

Lot or serial number

Not Applicable

Model or catalog number

10009061-X

10010766-X

 

Companies
Manufacturer

OMNYX, LLC

1251 Waterfront Place

Pittsburgh

15222

Pennsylvania

UNITED STATES