Brilliance and Ingenuity CT and ICT System (2016-05-02)

Starting date:

May 2, 2016

Posting date:

May 16, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-58402

• 
  Reason
• 
  Affected products

Affected products

1. BRILLIANCE 40/64 SLICE CT SYSTEM

2. BRILLIANCE ICT SYSTEM-SYSTEM

3. BRILLIANCE ICT SP SYSTEM-MAIN

4. INGENUITY CT SYSTEM

Reason

IMR cardiac - irregular appearance of contrast in vessels, missing image annotation's in cct, halo artifacts, incorrect Z annotation on plan box for coronal/sagittal surviews, unintended change of acquisition timing on scan ruler, bolus tracker does not trigger as expected, system unresponsive when paused, system becomes unresponsive during timed scan, unplanned results during multi-phase pulmo series, may cause a system crash, communication errors between host computer & gantry, incorrect phase tolerance for cardiac step & shoot, error when auto ROI placement outside patient anatomy, no "go" when HR is outside of acceptable range, console unresponsive when gantry cancels scan, unable to match Z locations on prescan and 4D CT scan, pin wheel artifact using 0.67mm slice width, tracker scan halted with fdom. (please contact manufacturer for details regarding reasons for recall)

Affected products