PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE AIR 40/64/UCT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
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Device Problem
Signal Artifact/Noise (1036)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Note: we have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.(b)(4).
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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 a ring artifact on brain studies.Engineering analysis has confirmed that this event has been determined to be a reportable issue due to the potential for image misinterpretation, because of a recognizable 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 a recognized ring artifact on brain studies.A philips field service engineer (fse) went onsite to evaluate the system.The fse investigated the system and determined the ring artifact was the result of a cracked compensator which is inside the a-plane collimator.The fse replaced the a-plane collimator assembly to resolve the issue.The fse confirmed that there was no harm to a patient, operator, or bystander; there was no image misinterpretation as a result of the artifact.The system is functional and in clinical use.This issue has been determined not to be a reportable event.
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Search Alerts/Recalls
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