FDAApril 16, 2021device
Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning
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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