Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail
-

Esprit Ventilator

Class I Recall

Date Recall
Initiated:
 June 8, 2001
Product:
 ESPRIT Ventilator Model V1000
Use:
 The device is a computer controlled, electrically powered, mechanical ventilator. It is intended to provide ventilatory support for adult and pediatric patients suffering breathing distress.
Recalling Firm:
 Respironics California, Inc.
2271 Cosmos Ct.
Carlsbad, California 92009
Reason for Recall:
 A material used to construct three check-valves in this ventilator predisposed them to premature failure. There have been two patient injuries resulting in partial or complete failure to permit ventilation.
Public Contact:
 Kathy Moore
Director, Quality Assurance/Regulatory Affairs
760-918-7321
FDA District:
 Los Angeles
FDA Comment:

There is a reasonable probability that use of the product presents a risk of serious adverse health consequences, including death.
-
-