Recall Z-1568-2022 ยท CBK Ventilator, Continuous, Facility Use
Getinge Usa Sales Inc
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)
| Date | Jul 21, 2022 |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Device Design |
| Action | 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 Vent |
| Quantity | US 102 units; OUS 13750 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia (AU), Brazil (BR), China (CN), Egypt (EG), EEA, Hong Kong (HK), Israel (IL), Japan (JP), Mexico (MX), Pakistan (PK), Saudi Arabia (SA), South Africa (ZA), South Korea (KR), Switzerland (CH), Taiwan (TW), Turkey (TR), and United Ar |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192604 | Servo-air 4.0 Ventilator System Maquet Critica Care AB, Jun 18, 2020 |