FDA-Device2022-08-31Class II
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)
Getinge Usa Sales Inc
Hazard
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
Sold states
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 Arab Emirates (AE).
Affected count
US 102 units; OUS 13750 units
Manufactured in
1 Geoffrey Way, Wayne, NJ, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1568-2022Don't want to check this manually?
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