Catalog Number 3009PX-LEX-450 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device was functionally/visually inspected in the field.The device was repaired and returned to use.2 devices were not evaluated and no cause was determined, as the customers did not make the devices accessible for testing.There was no remedial action taken.This device is not labeled for single use.
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Event Description
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This report summarizes 3 malfunction events, where it was reported the devices experienced accessible ac current.There was no patient involvement.
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Search Alerts/Recalls
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