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Model Number FC500 240V |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/20/2021 |
Event Type
malfunction
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Event Description
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The customer reported amp board errors at the fl1 and fl4 positions on their fc 500 flow cytometer.There was no report of death, injury, or change to patient treatment as a result of this event.
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Manufacturer Narrative
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Patient information is not applicable.There was no impact to patients as a result of this event.The field service engineer (fse) was on site and confirmed what the customer reported.To resolve the issue the fse replaced the tarpon amp boards at the affected locations (fl1 and fl4).Upon further review, this complaint was reassessed and will be reported late as it was determined that this event was in scope of the tarpon amp board recall.Bec is filing an mdr for this event based on the fda classification of the 08 jan 2018 urgent medical device recall as a class i recall on 20 nov 2018 (recall number z-0471-2019 for fc 500; recall number z-0472-2019 for epics xl/xlmcl).Bec internal identifier - case-(b)(4).
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Search Alerts/Recalls
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