Device Recall The CARESCAPE" Monitor B850 version 1.0.1.13 and 1.0.2.1

Parent SN : SED09451341GA SED09471459GA SED09471460GA SED09471461GA SED09471463GA SED09471464GA SED09471467GA SED09471468GA SED09471469GA SED09471470GA SED09471472GA SED09471474GA SED09471476GA SED09471480GA SED09471481GA SED09471486GA SED09471488GA SED09471491GA SED09471493GA SED09471496GA SED09471478GA SED09491583GA SED09491587GA SED09491595GA SED09491596GA SED09491597GA SED09491599GA SED09511674GA SED09511676GA SED10021713GA SED09310446GA SED09310448GA SED09310452GA SED09310453GA SED09310454GA SED09310456GA SED09310458GA SED09310461GA SED09310462GA SED09310468GA SED09310470GA SED09310477GA SED09310496GA SED09310498GA SED09310524GA SED09310525GA SED09320526GA SED09320527GA SED09320529GA SED09320530GA SED09320531GA SED09320532GA SED09320533GA SED09320534GA SED09320535GA SED09320536GA SED09320537GA SED09320539GA SED09320541GA SED09320542GA SED09320543GA SED09320545GA SED09320546GA SED09320547GA SED09320548GA SED09320549GA SED09320550GA SED09330585GA SED09340662GA SED09340663GA SED09370799GA SED09370802GA SED09370803GA SED09370804GA SED09370805GA SED09370806GA SED09370809GA SED09370811GA SED09370812GA SED09370813GA SED09370814GA SED09370815GA SED09370817GA SED09370819GA SED09370820GA SED09370821GA SED09370822GA SED09370825GA SED09370826GA SED09370827GA SED09370828GA SED09370829GA SED09370832GA SED09370833GA SED09390834GA SED09390835GA SED09390836GA SED09390838GA SED09390839GA SED09390840GA SED09390841GA SED09390842GA SED09390843GA SED09390847GA SED09390856GA SED09390857GA SED09390860GA SED09390874GA SED09390876GA SED09390877GA SED09390879GA SED09390882GA SED09390883GA SED09390890GA SED09400894GA SED09400896GA SED09400941GA SED09400945GA SED09400948GA SED09410954GA SED09420980GA SED09420990GA SED09420992GA SED09421001GA SED09451339GA SED09451340GA SED09451342GA SED09451344GA SED09451345GA SED09451346GA SED09451348GA SED09451369GA SED09471432GA SED09471462GA SED09471477GA SED09471494GA SED09491589GA SED09491592GA SED09491600GA SED09491601GA SED09491603GA SED09511667GA SED09511675GA SED10021683GA SED10021684GA SED10021707GA SED09370830GA SED09390846GA SED09390850GA SED09390852GA SED09390862GA SED09390863GA SED09390864GA SED09390865GA SED09390866GA SED09390869GA SED09390870GA SED09390873GA SED09390875GA SED09390878GA SED09390880GA SED09390881GA SED09390884GA SED09390885GA SED09390886GA SED09390887GA SED09390888GA SED09390889GA SED09390893GA SED09400897GA SED09400898GA SED09400899GA SED09400900GA SED09400901GA SED09400902GA SED09400903GA SED09400904GA SED09400905GA SED09400907GA SED09400909GA SED09400910GA SED09400911GA SED09400912GA SED09400913GA SED09400914GA SED09400915GA SED09400916GA SED09400917GA SED09400919GA SED09400920GA SED09400921GA SED09400922GA SED09400925GA SED09400943GA SED09400946GA SED09400949GA SED09400951GA SED09471490GA SED09451303GA SED09461399GA SED09461402GA SED09461406GA SED09461411GA SED09491519GA SED09491520GA SED09491522GA SED09491523GA SED09491524GA SED09491526GA SED09491527GA SED09491528GA SED09491534GA SED09491536GA SED09491537GA SED09491540GA SED09491543GA SED09491544GA SED09491545GA SED09491547GA SED09491548GA SED09491564GA SED09491565GA SED09491567GA SED09491569GA SED09491572GA SED09491575GA SED09491576GA SED09491577GA SED09491578GA SED09310466GA SED09310479GA SED09310482GA SED09310517GA SED09340628GA SED09340637GA SED09340647GA SED09370723GA SED09370725GA SED09370726GA SED09370727GA SED09370729GA SED09370730GA SED09370738GA SED09370739GA SED09370741GA SED09370744GA SED09370746GA SED09370747GA SED09370748GA SED09370749GA SED09370750GA SED09370752GA SED09370753GA SED09370798GA SED09421004GA SED09421006GA SED09421007GA SED09421009GA SED09421010GA SED09421011GA SED09431059GA SED09431063GA SED09431064GA SED09431065GA SED09431067GA SED09431068GA SED09431070GA SED09431071GA SED09431074GA SED09441078GA SED09441157GA SED09441158GA SED09441159GA SED09441160GA SED09441161GA SED09441162GA SED09441165GA SED09441168GA SED09441172GA SED09441173GA SED09441175GA SED09441177GA SED09441178GA SED09441180GA SED09441186GA SED09441189GA SED09441195GA SED09441198GA SED09441199GA SED09441200GA SED09441201GA SED09441202GA SED09441203GA SED09441204GA SED09441206GA SED09441207GA SED09441208GA SED09441209GA SED09441210GA SED09441211GA SED09441212GA SED09441277GA SED09441286GA SED09451311GA SED09451312GA SED09451313GA SED09451314GA SED09451315GA SED09451316GA SED09451318GA SED09451319GA SED09451322GA SED09451351GA SED09451366GA SED09451367GA SED09451368GA SED09451370GA SED09451371GA SED09451372GA SED09451373GA SED09451374GA SED09451375GA SED09451377GA SED09451378GA SED09461379GA SED09461380GA SED09461381GA SED09461382GA SED09461383GA SED09461384GA SED09461385GA SED09461386GA SED09461387GA SED09461388GA SED09461389GA SED09461390GA SED09461391GA SED09461392GA SED09461393GA SED09461394GA SED09461396GA SED09461397GA SED09461398GA SED09461400GA SED09461401GA SED09461403GA SED09461404GA SED09461405GA SED09461407GA SED09461408GA SED09461409GA SED09461410GA SED09461412GA SED09461414GA SED09461416GA SED09471431GA SED09471433GA 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Cardiovascular Devices

2

No

Worldwide distribution: USA including CO, MA, NC, WI, and countries of UNITED KINGDOM, SWITZERLAND, SWEDEN, SPAIN, SINGAPORE, PORTUGAL, NORWAY NETHERLANDS, ITALY, INDIA, GERMANY, FRANCE, FINLAND, BELGIUM, and AUSTRALIA.

GE Healthcare, CARESCAPE" Monitor B850, Software version 1.0.1.13 and 1.0.2.1 || The CARESCAPE " Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation)), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), C02 production (VCO2), energy expenditure (EE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI.