June 13, 2006

FDA ALERT

FDA MedWatch - Hamilton Medical RAPHAEL Ventilators: recall due to risk of failure of alarms

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Hamilton Medical, Inc. and FDA notified healthcare professionals of a recall of certain RAPHAEL model ventilators with older generation software, due to a software algorithm designed to suppress false positive alarms that may preclude any alarm (no visible or audible alarms are triggered).

Read the complete MedWatch 2006 Safety summary, including a link to the firm press release, at:

http://www.fda.gov/medwatch/safety/2006/safety06.htm#RAPHAEL