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U.S. Department of Health and Human Services

Class 2 Device Recall Espirit Ventilator

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  Class 2 Device Recall Espirit Ventilator see related information
Date Initiated by Firm June 01, 2001
Date Posted July 20, 2004
Recall Status1 Terminated 3 on May 12, 2004
Recall Number Z-0903-04
Recall Event ID 28803
510(K)Number K981072  
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Espirit Ventilator, Model V1000

Continuous Ventilator with Respiratory Mechanics
Code Information All Codes.
Recalling Firm/
Respironics California Inc
2271 Cosmos Ct
Carlsbad CA 92009-1517
For Additional Information Contact Anil Bhalani
Manufacturer Reason
for Recall
Ventilator would spontaneously suspend ventilatory support to patients due to a hardware/software compatibility issue.
FDA Determined
Cause 2
Action Firm technicians and foreign representatives were responsible for updating software on or about 6/1/01.
Quantity in Commerce 749
Distribution Nationwide, Argentina, Brazil, Canada, China, Chile, Egypt, India, Italy, Japan, Korea, Mexico, Pakistan, Panama, Philipines, Puerto Rico, Singapore, Spain, Thailand, Turkey, 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, INC.