Model Number 6002-680-000 |
Device Problems
Imprecision (1307); Application Program Freezes, Becomes Nonfunctional (4031); Intermittent Communication Failure (4038)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/05/2021 |
Event Type
malfunction
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Event Description
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It was reported that the device was inaccurate during a procedure.A second system was used to complete the procedure.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention was reported.
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Event Description
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It was reported that the device was inaccurate during a procedure.A second system was used to complete the procedure.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention was reported.
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Manufacturer Narrative
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Device evaluation: follow-up report submitted to document device evaluation results.H3 other text: the system log files were not available for review.
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Search Alerts/Recalls
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