Draeger Medical, Inc. recalls Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.

Recall date

February 4, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0827-2016

FDA classification

Class I

Brand / firm

Draeger Medical, Inc.

Sold / distributed

US Nationwide Distribution including Puerto Rico.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.