BiPAP Focus Non-Invasive Ventilator System, Respironics California
MedSun: Newsletter #39, August 2009

FDA Recall Notice

Respironics California, Inc. and FDA notified healthcare professionals of a Class I recall of the BiPAP Focus Non-Invasive Ventilator System, model number PCM120PS18-2315P. This device is used by healthcare professionals to treat adult patients who have advanced lung disease and/or have difficulty breathing. Power supply failures have occurred on some ventilators.

Additional Information:

FDA MedWatch Safety Alert. BiPAP Focus Non-Invasive Ventilator System, Respironics California. July 9, 2009.
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171242.htm

FDA CDRH Recall Notice. Respironics California Inc., BiPAP Focus Non-Invasive Ventilator System. July 9, 2009.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm171194.htm


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