Catalog Number 6007-616-000 |
Device Problems
Image Display Error/Artifact (1304); Imprecision (1307)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/29/2019 |
Event Type
malfunction
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Event Description
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It was reported by the user facility that during a procedure, there was an inaccuracy by the device, and at one point the inaccuracy was 15mm.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
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Manufacturer Narrative
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Device evaluation: follow-up report submitted to document device evaluation results.
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Event Description
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It was reported by the user facility that during a procedure, there was an inaccuracy by the device, and at one point the inaccuracy was 15mm.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
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Search Alerts/Recalls
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