Hamilton Medical is initiating a nationwide voluntary recall of three types of RAPHAEL ventilators with older generation software, the FDA said in a recent posting on its website. A total of 47 devices are being recalled.
Current RAPHAEL Color and RAPHAEL XTC ventilators are not affected by this action and only four customer facilities are affected, Hamilton said.
The recall is being initiated because, under certain conditions following an oxygen cell calibration without a compressed air supply, the ventilator "can be put into a state where no visible or audible alarms are triggered," the company said.
The recall announcement can be viewed at http://www.fda.gov/oc/po/firmrecalls/hamilton06_06.html (http://www.fda.gov/oc/po/firmrecalls/hamilton06_06.html).