FDADecember 1, 2015device

Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The firm became aware of cases in which the battery run times of the optional PS 500 power supply unit with the Infinity Workstation Critical Care (Evita Infinity V 500) were unexpectedly short due to the design of the charging algorithm in the current software. Devices used for patient transport will be a priority.

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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