Call Us: 1.800.873.5297


FDA Recalls Infant Apnea Monitor

On Monday, May 18, the FDA issued a class I recall for SmartMonitor 2 Infant Apnea Monitor. A class I recall is the highest recall level that can be issued and is only issued when a product has a reasonable probability of causing serious injury or death. The recalled Apnea monitor is manufactured by Respironics, a Pennsylvania based health care device manufacturer.

The SmartMonitor 2 is used by both hospitals and consumers alike. It is used as a monitoring device in order to continuously watch an infant’s breathing and heart rate. The recall was issued because the SmartMonitor2 can fail to alarm when an infant’s breathing stops or his/her heart rate drops to a dangerously low level. The models that are being recalled were manufactured between January 16, 2008 and November 13, 2008. They were distributed from January 13, 2008 to December 31, 2008. The model numbers being recalled include model 4002 and 4003. The serial numbers of the recalled models are 3000033364 through 3000038740. The FDA advises that all stop using the product immediately and to report any problems to their doctor and the FDA. Currently, there have been no recorded fatalities from this device.

More than 4,900 defective infant apnea monitors have been voluntarily recalled. The potential defect is the failure of the audible alarm, which may cause the alarm not to sound when it should. The FDA stated that on April 23, 2009 Respironics notified medical supply companies of the potential defect in the SmartMonitor 2 infant apnea monitors. Respironics wanted all monitors in the companies’ inventories retuned.
Customers with questions or concerns regarding the SmartMonitor2 infant apnea monitor recall may contact Respironics at 1-888-345-4630.The FDA requests that Health care professionals and consumers may report adverse reactions or quality problems related to the recalled infant apnea monitors to the FDA’s MedWatch Adverse Event Reporting program via:
Regular Mail: use postage-paid FDA form 3500 available at:
FAX: 1-800-FDA-0178

For more information please see:

000-017   000-080   000-089   000-104   000-105   000-106   070-461   100-101   100-105  , 100-105  , 101   101-400   102-400   1V0-601   1Y0-201   1Z0-051   1Z0-060   1Z0-061   1Z0-144   1z0-434   1Z0-803   1Z0-804   1z0-808   200-101   200-120   200-125  , 200-125  , 200-310   200-355   210-060   210-065   210-260   220-801   220-802   220-901   220-902   2V0-620   2V0-621   2V0-621D   300-070   300-075   300-101   300-115   300-135   3002   300-206   300-208   300-209   300-320   350-001   350-018   350-029   350-030   350-050   350-060   350-080   352-001   400-051   400-101   400-201   500-260   640-692   640-911   640-916   642-732   642-999   700-501   70-177   70-178   70-243   70-246   70-270   70-346   70-347   70-410   70-411   70-412   70-413   70-417   70-461   70-462   70-463   70-480   70-483   70-486   70-487   70-488   70-532   70-533   70-534   70-980   74-678   810-403   9A0-385   9L0-012   9L0-066   ADM-201   AWS-SYSOPS   C_TFIN52_66   c2010-652   c2010-657   CAP   CAS-002   CCA-500   CISM   CISSP   CRISC   EX200   EX300   HP0-S42   ICBB   ICGB   ITILFND   JK0-022   JN0-102   JN0-360   LX0-103   LX0-104   M70-101   MB2-704   MB2-707   MB5-705   MB6-703   N10-006   NS0-157   NSE4   OG0-091   OG0-093   PEGACPBA71V1   PMP   PR000041   SSCP   SY0-401   VCP550  

Legal Disclaimer & Privacy Policy
This web site is designed for general information only. The information presented should not be construed as legal advice and does not form the basis for an attorney/client relationship.

The choice of a lawyer is an important decision and should not be based solely on advertisements.
This web site is not intended to be advertising, and Schlichter Bogard & Denton LLP does not desire to represent anyone desiring representation based upon viewing this web site in a jurisdiction where this web site fails to comply with all laws and ethical rules of that jurisdiction. Materials on this web site may only be reproduced in their entirety (without modification) for the individual reader's personal and/or educational use and must include this notice.

We will not disclose, sell, or rent any of your identifiable personal information to any third party, unless approved by you, or required by law.