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Health product recall

CENTRICITY UNIVERSAL VIEWER - main Unit (2015-10-01)

Starting date:
October 1, 2015
Posting date:
October 22, 2015
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-55508

Affected Products

CENTRICITY UNIVERSAL VIEWER - main Unit

Reason

The products, when (1) deployed with centricity PACS and centricity enterprise archive, or (2) retrieving images from vendor neutral DICOM archives, display inaccurate measurements on magnification views acquired from certain digital x-ray systems because certain scanner-originated magnification factors are not taken into account by universal viewer.

Affected products

CENTRICITY UNIVERSAL VIEWER - main Unit

Lot or serial number

UV 5.0

Model or catalog number

2068179-X

Companies
Manufacturer
GE Healthcare
540 West Northwest Hwy.
Barrington
60010
Illinois
UNITED STATES