FDA-Device2016-03-02Class I
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
Draeger Medical, Inc.
Hazard
The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical and Neonatal Care was rapidly and unexpectedly reduced, despite using the most recent power supply firmware version 1.50 released in November 2015 (recall Z-0436-2016). The batteries were prematurely discharged, even though an adequate battery charge status was displayed on the device.
Sold states
US Nationwide Distribution including Puerto Rico.
Affected count
2553
Manufactured in
3135 Quarry Rd, N/A, Telford, PA, United States
Products
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0827-2016Don't want to check this manually?
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