BRILLIANCE CT AND INGENUITY CT SYSTEM (2015-09-17)

Starting date:

September 17, 2015

Posting date:

October 8, 2015

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-55298

• 
  Reason
• 
  Affected products

Affected Products

1. BRILLIANCE CT BIG BORE SYSTEM- MAIN UNIT
2. INGENUITY CT SYSTEM

Reason

• Issue 1: Image Position Accuracy - Image Rotation Calibration Program performed by field service representative can report pass but fail to produce the correct angular rotation offset value for the ultra-fast scan mode. The inaccurate angular rotation offset can impact the accuracy of radiation treatment planning.
• Issue 2: Tracker Image Artifact - tracker scan image of CT Angiography (CTA) examination can exhibit a streaking artifact. Due to the streaking artifact, the automatic clinical scan may be triggered at the wrong time resulting in suboptimal CT diagnostic images that do not capture the bolus peak of the imaged body section.
• Issue 3: Ring/Dot Image Artifact Due to X-ray Measurement - after a complete system power shutdown and power up, if a head scan is performed without air calibration and without quick IQ check scan after power up, intermittent ring/dot image artifacts in the reconstructed images may occur.

Affected products