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

• Reason
• Affected products

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