Hamilton Medical, inc. has issued a voluntary recall of Raphael ventilators with older software because, under certain specific situations following an oxygen cell calibration without a compressed air supply, as instructed by the operator’s manual, the ventilator can be put into a state where no visible or audible alarms are triggered.
The following RAPHAEL ventilators are being recalled:
RAPHAEL (Software version 2.2x)
RAPHAEL Silver (Software version 2.2xS)
RAPHAEL Color (Software version 2.2xC, 2.2xCU)
Customers with questions may contact the Company at 800-426-6331 for a complete set of documentation relating to this action. Anyone experiencing problems with the use of this or any other medical product should report the problem to the FDA’s MedWatch Program by phone at 1-800-FDA-1088 .