Smiths Medical Medfusion Model 4000 Syringe Infusion Pump: Class I Recall - System Errors May Cause Device Shutdown
MedSun: Newsletter #76, September 2012

FDA MedWatch Safety Alert

FDA notified healthcare professionals and medical care organizations of the Class I recall of all Model 4000 pumps with software Versions V1.0 and V1.1 due to system errors that can cause the Medfusion 4000 infusion pump to go into an alarm condition and stop running, resulting in a delay or an interruption of patient therapy.

Additional Information:

FDA MedWatch Safety Alert. Smiths Medical Medfusion Model 4000 Syringe Infusion Pump: Class I Recall - System Errors May Cause Device Shutdown. August 3, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm314367.htm


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