The device returned for analysis.The complaint investigation determined the reported difficulty was the result of a design related wear issue.After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag.Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.
|
It was reported that the centrimag motor was not detected by the console.The event occurred during system preparation.During the event, no patient were connected to the system.The customer tested the motor on other systems.The system error presented again.The suspect motor was returned for analysis.This event was previously not reported due to patient involvement.Abbott made the decision on july 13, 2018 to initiate a voluntary recall, therefore this event is being upgraded to reportable.
|