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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.
The FDA is encouraging device companies to use email and other forms of electronic communications such as fax or text messaging to
announce voluntary recalls of FDA-regulated products and other important device safety information to the public.
The FDA April 28 issued recommendations for health care providers to take additional safety steps when using the Colleague volumetric infusion pump manufactured by Baxter Healthcare.