Press release Gothenburg, Sweden, on September 23, 2020
Getinge is announcing a voluntary recall of the Servo-i ventilator system’s nebulizer connector
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.
Anna Appelqvist, Vice President Corporate Communications
Phone: +46 (0)10 335 5906
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions that aim to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 10,000 people worldwide and the products are sold in more than 135 countries.