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Health product recall

Brilliance 6/10/16 Slice CT System - Extended Brilliance Workspace Portal

Starting date:
September 14, 2012
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Assistive/Medical Devices
Audience:
General Public (GP), Healthcare Professionals, Hospitals
Identification number:
RA-15113

Reason

When performing post processing with the Brilliance Workspace Portal Platform with Software Version 2.6.1.4, the coronary arteries in the rendered image are segmented automatically. However, the centre line is not extracted or highlighted upon hovering and making it impossible to activate the vessel and choose the appropriate name (label) from the drop-down menu. As a result the operator has to manually extract the relevant vessel using the centerline extraction tools. Once extracted, it will allow the user to view and label the coronary artery.

Affected products

Brilliance 6/10/16 Slice CT System - Extended Brilliance Workspace Portal

Lot or serial number

N/A

Model or catalog number

4550 110 02101

Companies

Manufacturer

Philips Medical Systems (Cleveland) Inc.


Brilliance 40/64 Slice CT System - Extended Brilliance Workspace Portal

Lot or serial number

N/A

Model or catalog number

4550 110 02101

Companies

Manufacturer

Philips Medical Systems (Cleveland) Inc.