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FDA > CDRH > Medical Device Recalls > Class I Recall - Espirit Ventilator

Medical Device Recalls
Class I Recall - Espirit Ventilator

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.

For additional information on this product recall, see the FDA Enforcement Report located at: http://www.fda.gov/bbs/topics/Enforce/2003/ENF00803.html Scroll down to "Recalls and Field Corrections: Devices – Class I"

Updated July 10, 2003

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