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U.S. Department of Health and Human Services

Medical Devices

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Respironics, Inc., SmartMonitor 2 Infant Apnea Monitor (Models 4002 and 4003)

Recall Class:
Class I
Date Recall
Initiated:
April 23, 2009
Product:

Respironics, Inc., SmartMonitor 2 Infant Apnea Monitor (Models 4002 and 4003 with serial numbers 3000033364 through 3000038740)

This product was manufactured from January 16, 2008 through November 13, 2008 and distributed from January 17, 2008 through December 31, 2008.

Use:
This device is used for the continuous monitoring of respiration and heart rate of infant patients in the home or in the hospital. The monitor detects and alarms for periods of temporary interruption of breathing (central apnea) or low heart rates.
Recalling Firm:
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, Pennsylvania 15668-8517
Reason for Recall:
This device may fail to sound an alarm.
Public Contact:
Customers may contact the company at 1-888-345-4630.
FDA District:
Philadelphia
FDA Comments:

On April 23, 2009, the firm sent a letter to their medical supply companies informing them of the potential problem. The firm requested the companies take the following actions:

  • return all units in their inventory
  • retrieve and return all units already shipped to patients

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.