BRILLIANCE CT AND INGENUITY CT SYSTEM (2015-09-17) — recall 54299
Health Canada — Medical Devices · Canada · 2015-10-08 · Type II
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Reported risk: 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.
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