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Health product recall

INTELEPACS (2016-08-05)

Starting date:
August 5, 2016
Posting 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-59972

Affected Products

INTELEPACS

Reason

Intelerad has identified a software problem in the image fusion module which may display an incorrect calculation of standard uptake value (SUV) when loading the presentation state of image for a previously calculated (and saved) region of interest (ROI).

Affected products

INTELEPACS

Lot or serial number

V4.10.1 and earlier

Model or catalog number

INTELEPACS

Companies
Manufacturer
Intelerad Medical Systems Incorporated
895 De La Gauchetiere Street West, 4th floor
Montreal
H3B 4G1
Quebec
CANADA