Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in different configurations. It supports a variety of breathing modes and can be used for Neonates, Pediatric and Adults.

A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully.

On September __, 2020, the firm issued an Urgent Medical Device Recall letter to affected customers. Distributors were instructed to forward the information to all current and potential Servo-i Ventilator System users and biomedical staff within hospitals/facilities. Customers were asked to examine their inventory immediately to determine if they have any products with the listed serial numbers. For affected units, an alternate means of nebulization would need to be readily available and used until the unit correction can be performed by the Getinge Service Technician if nebulization via the Servo-i Aeroneb Nebulization module be required. Customers were also asked to complete and return the response form to the firm to acknowledge their receipt of the notification. If you have one or more affected systems, you will be contacted by a Getinge Service Representative to schedule on-site correction of your device as soon as an update kit is available. Affected devices will be corrected free of charge. You can also arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Customer Technical Support at (888) 9438872 (select option 1, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). You may also call this number if you have any questions about this recall.