FDA recall Z-1568-2022

Getinge Usa Sales Inc · Class II · device

Product

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)

Reason for recall

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

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 Arab Emirates (AE).

Key facts

Status
Ongoing
Initiation date
2022-07-21
Report date
2022-08-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1568-2022