Model Number 0475100000 |
Device Problem
Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/13/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Alleged failure: set up 2 towers turned everything on and the e43 code appeared the failure(s) identified in the investigation is consistent with the complaint record.The root cause is the rf board.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.No manufacturing date: the device manufacturer date is not known.
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Event Description
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It was reported that there was a thermal event.
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Manufacturer Narrative
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Alleged failure: set up 2 towers turned everything on and the e43 code appeared the failure(s) identified in the investigation is consistent with the complaint record.The root cause is the rf board.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that there was a thermal event.
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Search Alerts/Recalls
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