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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm February 20, 2002
Date Posted July 28, 2004
Recall Status1 Terminated 3 on December 02, 2004
Recall Number Z-1230-04
Recall Event ID 29385
510(K)Number k981072  k001208  k023350  k034040  
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Esprit Ventilator
Code Information Too numerous to include.
Recalling Firm/
Respironics California Inc
2271 Cosmos Ct
Carlsbad CA 92009-1517
For Additional Information Contact Anil Bhalani
Manufacturer Reason
for Recall
Flow sensors would exhibit drift.
FDA Determined
Cause 2
Action Oxygen flow sensors were replaced in all ventilators by service technicians in the USA. Parts were given to foreign consignees. Recall is complete.
Quantity in Commerce 907
Distribution Nationwide, 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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = RESPIRONICS CALIFORNIA, INC.
510(K)s with Product Code = CBK and Original Applicant = RESPIRONICS, INC.