Model Number 728231 |
Device Problems
Signal Artifact/Noise (1036); Degraded (1153)
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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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We have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.Internal cross reference: (b)(4).
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Event Description
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Engineering analysis concluded that this event has the potential to result in image misinterpretation due to an artifact from a degraded compensator within the collimator.Therefore, this issue has been determined to be a reportable event.
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Manufacturer Narrative
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The customer reported that a ring artifact appeared on scanned images.There was no report of misrepresentation as a result of the artifact.The philips field service engineer (fse) confirmed the reported issue that a ring artifact was present on scanned images.The fse visually inspected the system and found a crack in the compensator within the a-plane collimator.The fse replaced the a-plane collimator to resolve the issue.The philips fse confirmed the patient was scanned on a magnetic resonance imaging (mri) system.There was no harm to the patient.The system is in clinical use.This issue was determined not to be a reportable event.
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Search Alerts/Recalls
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