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Health product recall

Merge PACS

Starting date:
August 26, 2016
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-60212

Affected Products

Merge PACS

Reason

This recall has been initiated due to merge PACS inability to display presentation states on prior comparison studies generated on 3rd party systems or that have been migrated from Office PACS. PACS 6.5.6 introduced the feature to be able to display foreign presentation states, however, this feature was only available on the primary study in any given viewer instance. It did not apply to prior comparison studies that were opened in the same viewer. Users might assume that if the annotations are available in the primary study, they would also be shown if available on the prior comparison studies.

Affected products

Merge PACS

Lot or serial number

6.5.5
6.5.6
6.5.7
6.5.8
6.5.9
6.6.0
6.6.1
6.6.1.1
6.6.2

Model or catalog number

MERGE PACS

Companies
Manufacturer
Merge Healthcare Incorporated,
900 Walnut Ridge Drive,
Hartland
53029
Wisconsin
UNITED STATES