Class 2 Device Recall Respironics

• Date Initiated by Firm: September 02, 2002
• Date Posted: July 20, 2004
• Recall Status: Terminated on July 06, 2004
• Recall Number: Z-1049-04
• Recall Event ID: 29378
• 510(K)Number: K032755 K993979 K000794
• 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
• FEI Number: 1219324
• 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: 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; 510(K)s with Product Code = DQA