Getinge is announcing a voluntary medical device recall for the Servo-i ventilator system due to a potentially shorter than specified nebulizer connector. This issue does not affect the functionality of the Servo-i ventilator system. To date, there have been no adverse events reported resulting in serious illness or injuries related to the mentioned component. Getinge has reported to relevant authorities according to applicable regulations and the cost for the recall is not material.
Getinge has identified that 997 units have been manufactured that potentially could be affected by a shorter than specified nebulizer connector. This may result in difficulties in installing the Aeroneb® Nebulizer module to the Servo-i device. The module is an option on the Servo-i which is intended for administering drugs to patients requiring mechanical ventilation. This issue does not affect the functionality of the Servo-i ventilator system.
The Servo-i ventilator is intended for ventilator support and can be used for Neonatal, Pediatric and Adult patients.
Concerned customers have received communication from Getinge.
This information is released in order to inform users of mentioned Getinge products, according to standard procedures recommended by regulatory authorities.