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U.S. Department of Health and Human Services

Class 1 Device Recall SmartMonitor 2 Infant Apnea Monitor

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  Class 1 Device Recall SmartMonitor 2 Infant Apnea Monitor see related information
Date Initiated by Firm April 23, 2009
Date Posted May 19, 2009
Recall Status1 Terminated 3 on October 19, 2011
Recall Number Z-1411-2009
Recall Event ID 51886
510(K)Number K011597  
Product Classification Monitor, apnea, facility use - Product Code FLS
Product SmartMonitor 2 Infant Apnea Monitor.

The monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of central apnea and high or low heart rates.
Code Information Model Number 4002; Serial Numbers 3000033364 through 3000038740 and Model Number 4003; Serial Numbers 3000033364 through 3000038740.
Recalling Firm/
Respironics, Inc.
1001 Murry Ridge Ln
Murrysville PA 15668-8517
For Additional Information Contact Customer Service
Manufacturer Reason
for Recall
Audible alarm failure.
FDA Determined
Cause 2
Process design
Action A notification letter dated April 23, 2009 was issued to consignees informing them of the issue. Consignees were instructed to locate the affected units in their inventory and return them to Philips Children's Medical Ventures-Youngwood Service. Any units that were shipped by consignees to their customers are to be retrieved and returned to Respironics. Consignees were also instructed to complete the enclosed Business Reply Form and Serial Number Reconciliation List and fax to Stericycle at 888-345-5369 or email to respironics1985@stericycle.com. For questions and additional information about the recall, contact Stericycle Customer Service by calling at 888-345-4630.
Quantity in Commerce 4,992 units
Distribution Nationwide and Canada.
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 = FLS and Original Applicant = RESPIRONICS GEORGIA, INC.