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U.S. Department of Health and Human Services

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Hamilton Medical, Inc. RAPHAEL Ventilators

Audience: Respiratory healthcare professionals and hospital risk managers

[Posted 06/12/2006] 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). The following RAPHAEL ventilators are affected:

RAPHAEL (Software version 2.2x)
RAPHAEL Silver (Software version 2.2xS)
RAPHAEL Color (Software version 2.2xC, 2.2xCU)

[June 06, 2006 - Press Release - Hamilton Medical, Inc.]