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Model Number V60 |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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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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Date of event: (b)(6) 2020.Date of report: 30oct2020.
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Event Description
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The customer reported a failure in the navigation ring.The unit was in clinical use at the time the reported issue was discovered; however, there was no harm to the patient or the user.
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Manufacturer Narrative
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G4: 18nov2020.B4: 19nov2020.The manufacturer¿s international service technician could not confirm the reported issue.A failure in the navigation ring was unable to be confirmed.The manufacturer¿s international service technician replaced the front bezel preventively to address the reported problem.The unit successfully passed the required performance verification test.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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Manufacturer Narrative
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G4:20feb2021.B4:04mar2021.H11:g5:k102985.H10: the front bezel was returned to failure investigation for testing and evaluation.All test passed.The returned user interface (ui) front bezel assembly was tested with no functional failures being identified.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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Search Alerts/Recalls
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