FDAFebruary 4, 2016device
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
draeger medicaldraeger
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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