PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE AIR 40/64/UCT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
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Catalog Number III |
Event Type
malfunction
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Event Description
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This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The customer reported that intermittently, ring artifacts displayed in ct head images.A philips field service (fse) confirmed the compensator was cracked and was causing the intermittent ring artifacts.Engineering analysis has confirmed that this event has been determined to be a reportable issue due to the potential for image misinterpretation, because of an artifact.Therefore, this issue has been determined to be a reportable event.This event is currently under investigation.
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Manufacturer Narrative
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The customer reported that during a patient procedure, the images exhibited ring artifacts.The philips field service engineer (fse) evaluated the system and confirmed there was a crack in the compensator.The fse replaced the a-plane collimator to resolve the issue.The philips fse confirmed there was no harm to a patient, operator, or bystander.The system is in clinical use.This issue was determined not to be a reportable event.
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