Health product recall

Brilliance CT Big Bore System-Main Unit (2018-01-05)

Starting date:
January 5, 2018
Posting date:
January 29, 2018
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-65736

Affected products

Brilliance CT Big Bore System-Main Unit

Reason

Philips became aware of issues with Brilliance Big Bore CT systems running software version 4.2.0. The most significant issues are:

  • Issue #1: EFOV (extended field of view) check message does not display when FOV is set > 600mm for a paused scan
  • Issue #2: Prefer “center x/y 0” and “disable result rotation” checkboxes checked automatically when checking the ""CT Simulation""
  • Issue #3: Tumor LOC allows POI (Point of Interest) locking when a non-isocenter slice is displayed
  • Issue #4: Tracker scan completed, no images were generated
  • Issue #5: Continuous Link plans the clinical scan outside the Surview
  • Issue #6: Applying tilt on first mpr result, when the other axial results are unplanned causes change in scan length and number of cycles of scan
  • Issue #7: “System is still initializing. Please wait…” error
  • Issue #8: Auto locations not functioning as expected
  • Issue #9: System ended exam before completion
  • Issue #10: System Freeze-Up after Pause is pressed

Affected products

Brilliance CT Big Bore System-Main Unit

Lot or serial number

Not applicable

Model or catalog number

728244

Companies
Manufacturer

Philips Medical Systems (Cleveland) Inc.

595 Miner Road

Cleveland

44143

Ohio

UNITED STATES