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Respironics Issues Class I Recall of SmartMonitor 2 Infant Apnea Monitors

May 18, 2009 | Parker Waichman LLP

Respironics, Inc. of Murrysville, PA  is voluntarily recalling more than 4,900 defective infant apnea monitors.  According to the company's  notice, the recall of its SmartMonitor 2 infant apnea monitors is being conducted due to the possibility of an audible alarm failure, which could cause the device to fail to issue an alarm when needed.

The SmartMonitor 2 infant apnea monitors are 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 interrupted breathing and high or low heart rates.

The SmartMonitor 2 infant apnea monitors subject to this recall were manufactured from January 16, 2008 through November 13, 2008 and distributed from January 17, 2008 through December 31, 2008.   The recall includes models 4002 and 4003 with serial numbers 3000033364 through 3000038740.

According to the Food & Drug Administration (FDA), Respironics sent a letter dated April 23, 2009 to  medical supply companies informing them of the potentially defective SmartMonitor 2 infant apnea monitors. The firm requested the companies return all units in their inventory.  The supply firms were also asked to  retrieve and return all units already shipped to patients.

The FDA has classified the Respironics SmartMonitor 2 infant apnea monitor recall a Class I recall, the agency's most serious type.  Class I recalls are issued when there is a  reasonable probability that use of a device will cause serious injury or death.  

Customers with questions regarding the SmartMonitor2 infant apnea monitor recall may  contact  Respironics at 1-888-345-4630.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these recalled infant apnea monitors to the FDA's MedWatch Adverse Event Reporting program via:

  • Online: www.fda.gov/MedWatch/report.htm
  • Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
  • FAX: 1-800-FDA-0178

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