Getinge announces voluntary recall of the ROTAFLOW drive unit

Getinge is announcing a voluntary global medical device recall of the ROTAFLOW drive unit. To date, there are no known adverse events associated with illness or injuries related to the drive unit. Getinge has reported to relevant authorities according to applicable regulations and the cost for the field correction and recall is not material.

The ROTAFLOW Centrifugal Pump System is a device that is indicated as a component of the extracorporeal circuit for pumping blood. Getinge is initiating a voluntary Medical Device Recall for the ROTAFLOW Drive Unit due to a loose coaxial cable connection that may result in fluctuating flow values on the ROTAFLOW Console.

This information is released in order to inform users of mentioned Getinge products, according to standard procedures recommended by regulatory authorities.

Getinge has the release.            

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