FDA Device

Esprit Ventilator.

Hazard

Valves may stick in the closed position due to manufacturing error.

What You Should Do

Remedy

Uninstalled ventilators were returned for change of the inhalation module. Otherwise, service technicians replaced the module in the field. Recall is complete.

Products

Esprit Ventilator.
Brand
Respironics California Inc
UPC
Serial numbers: VS300430, VS3004361, VS3004335, VS3004301, VS3004327, VS3004353, VS3004377, VS3004366, VS3004328, VS3004337, VS3004357, VS3004385, VS3004369, VS3004295, VS3004310, VS3004292, VS3004305, VS3004381, VS3004296, VS3004299.

Units Affected

20