ClearanceBrief
Recall Z-1230-04 ยท CBK Ventilator, Continuous, Facility Use

Respironics California Inc

Esprit Ventilator

DateJul 28, 2004 (initiated Feb 20, 2002)
StatusTerminated
ReasonFlow sensors would exhibit drift.
Root causeOther
ActionOxygen flow sensors were replaced in all ventilators by service technicians in the USA. Parts were given to foreign consignees. Recall is complete.
Quantity907
DistributionNationwide, Australia, Argentina, Brazil, Canada, Chile, Colombia, Spain, Germany, Hong Kong, India, Italy, Japan, Korea, Mexico, Malaysia, Panama, Philipines, Pakistan, Puerto Rico, Singapore, Thailand, Turkey, Taiwan, Venezuela Vietnam
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K001208ESPIRT
Respironics, Inc., May 12, 2000
K023350ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS
Respironics California, Inc., Nov 6, 2002
K034040ESPRIT VENTILATOR, MODEL V1000
Respironics, Inc., Jan 21, 2004
K981072ESPRIT VENTILATOR
Respironics, Inc., Nov 12, 1998