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Model Number 6500 |
Device Problem
Image Display Error/Artifact (1304)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/29/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported that the device displayed error code lec1720.There had been no issue related to physical damage/abuse, and it was unknown if the unit had been dropped.There was no patient involvement and no patient harm reported.
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Search Alerts/Recalls
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