GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH)
MedSun: Newsletter #64, September 2011

FDA MedWatch Safety Alert

The HCH device may have an occlusion that can prevent proper flow of the medical gases or oxygen, possibly resulting in insufficient oxygen delivered to the patient. Customers have been directed to NOT use the anesthesia circuits containing the Vital Signs Devices Passive Humidification Device (Hygroscopic Condenser Humidifier, or "HCH"), or the stand alone HCH device with the affected product item numbers and lot numbers, and to isolate all affected product.

Additional Information:

FDA MedWatch Safety Alert. GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH). August 3, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm266580.htm


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