FDA Recall of Class I SmartMonitor 2 Infant Apnea Monitor

Posted by H. Sandra Chevalier-Batik

MedWatch – The FDA Safety Information and Adverse Event Reporting Program

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

Audience: Consumers, Pediatricians
Respironics and FDA notified healthcare professionals of a Class I recall of SmartMonitor 2 Infant Apnea Monitor, Models 4002 and 4003, used for the continuous monitoring of respiration and heart rate of infant patients in the home or in the hospital. The monitors may fail to sound an alarm during periods of temporary interruption of breathing or low heart rates. The affected products were manufactured from January 16, 2008 through November 13, 2008 and distributed from January 17, 2008 through December 31, 2008.

Read the complete MedWatch 2009 Safety summary, including a link to the FDA recall notice, at:

http://www.fda.gov/medwatch/safety/2009/safety09.htm#SmartMonitor

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Tags: Class I SmartMonitor 2 Infant Apnea Monitor • FDA Recall • MedWatch 2009 Safety Summary

This entry was posted by H. Sandra Chevalier-Batik on May 18, 2009 at 12:25 pm and filed under FDA Product Recall. Bookmark the permalink. Follow any comments here with the RSS feed for this post. Post a comment(Latest is displayed first) or leave a trackback: Trackback URL.

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