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Model Number V60 |
Device Problems
Image Display Error/Artifact (1304); Defective Component (2292)
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Patient Problem
No Patient Involvement (2645)
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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: 16mar2020.
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Event Description
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It was reported that the unit's display was flashing and the navigation ring would not move.There was no patient involvement.
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Manufacturer Narrative
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G4: 07may2020.B4: 08may2020.The manufacturer's field service engineer (fse) performed troubleshooting at the customer's site.The fse replaced the navigation ring/front bezel and the issue was resolved.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: 12feb2021.D4: udi#: (b)(4).H11: g5: k102985.H10 the replaced front bezel was returned for failure analysis.It was determined to be due to liquid ingress caused the reported navigation ring failure.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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