FDA Device

Evita 4 Continuous Ventilator

Hazard

software problems - ventilation mode changes without user input, settings change without corresponding display change, false auto-set alarm.

What You Should Do

Remedy

The recalling firm issued recall letters to the accounts dated 5/7/03.

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Products

Evita 4 Continuous Ventilator
Brand
Draeger Medical, Inc.
UPC
Catalog numbers 4116640 and 8412980

Units Affected

806 units

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