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/ Manufacturer |
Respironics Novametrix, Inc. 5 Technology Dr Wallingford CT 06492-1942
|
For Additional Information Contact |
Kevin Nadar 203-697-6466
|
Manufacturer Reason for Recall |
Audio alarm may fail to sound when SpO2 limits drop below the set limits
|
FDA Determined Cause 2 |
Other |
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.
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