Home / Recalls / Medical Devices
Draeger Medical, Inc. recalls Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
Recalled March 2, 2016 · FDA recall Z-0827-2016 · Draeger Medical
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. · FDA Class I
Units
2553
Sold at
US Nationwide Distribution including Puerto Rico.
Description
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.
Product
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
Manufacturer(s)
Draeger Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →