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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