Model Number TABLETOP |
Device Problem
Optical Problem (3001)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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.(b)(4).
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Event Description
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A customer reported experiencing low lighting on the primary and secondary light source of the system.Additional information has been requested.
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Manufacturer Narrative
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The company service representative examined the system and replicated the reported event.The nonconforming primary and secondary illuminator modules were replaced to resolve the issue.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to the nonconforming primary and secondary illuminator modules.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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