Recall of Device Recall CARESCAPE

Model No. 2042084-001. Serial No. SA314096842GA, SA314212130GA, SA313430730GA, SA313430743GA, SA313430731GA, SA313430735GA, SA313430771GA, SA313430795GA, SA313430801GA, SA313430806GA, SA313430813GA, SA313441307GA, SA313441311GA, SA313441399GA, SA313441414GA, SA313441474GA, SA314086697GA, SA313272250GA, SA313378480GA, SA313419589GA, SA313430691GA, SA313430697GA, SA313430700GA,  SA313430705GA, SA313430706GA, SA313430711GA, SA313430713GA,  SA313430715GA, SA313430723GA, SA313430724GA, SA313430751GA, SA313430752GA, SA313430753GA, SA313430755GA, SA313430757GA, SA313430759GA, SA313430761GA, SA313430762GA, SA313430763GA, SA313430764GA, SA313430766GA, SA313430767GA, SA313430777GA, SA313430779GA, SA313430780GA, SA313430781GA, SA313430783GA, SA313430784GA, SA313430789GA, SA313430790GA, SA313430792GA, SA313430793GA, SA313430794GA, SA313430796GA, SA313430797GA, SA313430798GA, SA313430799GA, SA313430802GA, SA313430804GA, SA313430805GA, SA313430807GA, SA313430808GA, SA313430809GA, SA313430812GA,SA313430815GA, 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Cardiovascular Devices

2

No

Worldwide Distribution - US including NY, WI; Foreign: Australia, France, Germany.

CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software || The PDM is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes EGG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes.