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U.S. Department of Health and Human Services

Class 2 Device Recall Respironics

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  Class 2 Device Recall Respironics see related information
Date Initiated by Firm September 02, 2002
Date Posted July 20, 2004
Recall Status1 Terminated 3 on July 06, 2004
Recall Number Z-1049-04
Recall Event ID 29378
510(K)Number k993979  k000794  k032755  
Product Classification Oximeter - Product Code DQA
Product Model 509M Pulse Oximetry Interface Module
Software versions 2.0 or 2.5
Code Information Software versions 2.0 or 2.5
Recalling Firm/
Respironics Novametrix, Inc.
5 Technology Dr
Wallingford CT 06492-1942
For Additional Information Contact Kevin Nadar
Manufacturer Reason
for Recall
Audio alarm may fail to sound when SpO2 limits drop below the set limits
FDA Determined
Cause 2
Action Respironics notified customers by letter dated 9/3/02 of the problem with the failure of the audible alarm. A correction would require replacement of the speaker. Non-responders were recontacted by second letter on 2/24/2004.
Quantity in Commerce 901 units
Distribution AK, AZ, CA, CT, FL, NY, NM, PA, OK, TX,
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 = DQA and Original Applicant = NOVAMETRIX MEDICAL SYSTEMS, INC.
510(K)s with Product Code = DQA and Original Applicant = RESPIRONICS NOVAMETRIX, INC.