Draeger Medical Inc., Infinity Acute Care System Monitoring Solution (M540)
MedSun: Newsletter #68, January 2012
FDA MedWatch Safety Alert
FDA notified healthcare professionals of a Class I recall of the Infinity Acute Care System Monitoring Solution (M540), Catalog number MS25510. This product was manufactured from March 1, 2011 through September 30, 2011 and distributed only to the Rush University Medical Center (Chicago, Illinois) from July 1, 2011 through September 30, 2011. All serial numbers are affected by this recall. This product is a networked system used to monitor a patient’s vital signs and therapy, review Web-based diagnostic images, and access patient records. This recall is being issued due to incorrect dosage values and vital signs delays at the Infinity Central Station, which could cause serious health consequences to the patient.
FDA MedWatch Safety Alert. Draeger Medical Inc., Infinity Acute Care System Monitoring Solution (M540). December 6, 2011.