Recall of Certain Infant Apnea Monitors

Philips/Respironics is recalling some of the company's SmartMonitor 2 Infant Apnea Monitors. These devices are used to monitor infants' heart rate and respiration in the hospital or at home. The monitors are being recalled because they may fail to alarm if the infant experiences breathing problems or an abnormal heart rate.

The affected devices are the SmartMonitor 2, Models 4002 and 4003 with serial numbers 3000033364 through 3000038740.

In April 2009, the company notified their distributors about the problem and asked them to return all recalled monitors in their inventory, and also to retrieve and return all of these monitors that have been shipped to patients. If hospitals or caregivers think they may have one of the affected monitors, they should contact their medical supply distributor, or call Respironics directly at 1-888-345-4630.

FDA Patient Safety News: August 2009

For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=89#3

Category:

Education

Tags:

• Philips
• Respironics
• SmartMonitor2
• sleep apnea
• apnea monitor
• SIDS
• infant
• FDA