FDA Recall of Class I SmartMonitor 2 Infant Apnea Monitor

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

PG

Author: H. Sandra Chevalier-Batik

I started the Inconvenient Woman Blog in 2007, and am the product of a long line of inconvenient women. The matriarchal line is French-Canadian, Roman Catholic, with a very feisty Irish great-grandmother thrown in for sheer bloody mindedness. I am a research analyst and author who has made her living studying technical data, and developing articles, training materials, books and web content. Tracking through statistical data, and oblique cross-references to find the relevant connections that identifies a problem, or explains a path of action, is my passion. I love clearly delineating the magic questions of knowledge: Who, What, Why, When, Where and for How Much, Paid to Whom. My life lessons: listen carefully, question with boldness, and personally verify the answers. I look at America through the appreciative eyes of an immigrant, and an amateur historian; the popular and political culture is a ceaseless fascination. I have no impressive initials after my name. I’m merely an observer and a chronicler, an inconvenient woman who asks questions, and sometimes encourages others to look at things differently.