Model Number 7700-800-000 |
Device Problems
Imprecision (1307); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2021 |
Event Type
malfunction
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Event Description
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It was reported that during a procedure at the user facility the system was lagging.The system also shut down during use.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 the device was not available for evaluation.H3 other text : no product return per the customer.
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Event Description
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It was reported that during a procedure at the user facility the system was lagging.The system also shut down during use. 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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