Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 6881999 mobile cart)

Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended to be used on the floor or on a table shall be permanently marked with a clearly legible warning of this risk

Maquet Critical Care AB/Getinge issued Urgent Medical Device Correction letter to US consignees on 7/21/22 for delivery on Monday, July 25th via FedEX. If you have a Servo-air Ventilator System with one or more of the serial numbers listed on page 1 of this notification, a Getinge trained or authorized service technician will affix Symbol, ISO 7010:P019 "Do not step", (according to IEC 60601-1) to your Servo-air Ventilator system. Letter states reason for recall, health risk and action to take: 1. Please examine your inventory immediately to determine if you have received any Servo-air Ventilator devices with one of the affected serial numbers. 2. If you have a Servo-air Ventilator device affected by this field correction, please complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE FORM (page 6). Your affected device/(s) will be corrected during your next planned maintenance or other service visit. However, if you do not maintain a service contract with Getinge, you may contact Getinge to arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Tech Support at (888) 9GETUSA / (888) 943-8872 (select option 4, then option 2), between the hours of 8:00 a.m. and 6:00 p.m. Eastern Standard Time. This correction will be performed at no cost to your facility. 3. Please return the completed form to Getinge by emailing a scanned copy to [email protected] or by faxing the form to 1(973) 860-2462. 4. Whether or not you have affected product(s) with the serial numbers listed in this notice, please complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE FORM (page 6) to acknowledge that you have received this notification, per the instruction in number 3 above. 5. Please forward this information to all current and potential Servo-air Ventilator System users within your hospital/facility. 6. If you are a distributor who has shipped any affected products to customers, please forward this document to t