Devices

Device Recall CARESCAPE MONITOR B850

  • Model / Serial
    Parent Serial Number SED10102064GA SED10102074GA SED10102077GA SED10102078GA SED10102087GA SED10102088GA SED10102089GA SED10102094GA SED09441082GA SED10021717GA SED10021718GA SED10021722GA SED10031770GA SED10031772GA SED10031776GA 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 SED09451339GA SED09451340GA SED10061886GA SED09400941GA SED09400945GA SED09400948GA SED10021730GA SED10031735GA SED10031744GA SED10031749GA SED10071894GA SED10071896GA SED10071901GA SED10071902GA SED10071903GA SED10071904GA SED10071907GA SED10071913GA SED10071914GA SED10071916GA SED10071920GA SED10071921GA SED10071931GA SED10071937GA SED10081947GA SED10081955GA SED10081956GA SED10081959GA SED10081961GA SED10081962GA SED10081964GA SED10081965GA SED10081966GA SED10081969GA SED10081973GA SED10081976GA SED10081981GA SED10081984GA SED10081985GA SED10081986GA SED10081988GA SED10081989GA SED10081990GA SED10081994GA SED10081995GA SED10081997GA SED10082004GA SED10082007GA SED10082008GA SED10082009GA SED10082011GA SED10082012GA SED10082015GA SED10082016GA SED10082018GA SED10082019GA SED10082020GA SED10082021GA SED10082022GA SED10092030GA SED10092032GA SED10102082GA SED10102083GA SED10212790GA SED10212791GA SED10212792GA SED10212793GA SED10212794GA SED10212795GA SED10071918GA SED10082013GA SED10092038GA SED10102053GA SED10112141GA SED10112151GA SED10112161GA SED10112175GA SED10112182GA SED10112193GA SED10112194GA SED10112195GA SED10112196GA SED10112197GA SED10112247GA SED10112248GA SED10112258GA SED10112261GA SED10112264GA SED10122298GA SED10122300GA SED10122308GA SED10122336GA SED10132449GA SED10132450GA SED10132453GA SED10132456GA SED10132458GA SED10132462GA SED10132464GA SED10122318GA SED10122352GA SED10122361GA SED10122363GA SED10122365GA SED10122371GA SED10122372GA SED10122373GA SED10122375GA SED10122376GA SED10122377GA SED09451348GA SED09471462GA SED10132382GA SED10132386GA SED10132390GA SED10132400GA SED10132404GA SED10132405GA SED10132406GA SED10132411GA SED10132416GA SED10132419GA SED10132431GA SED09330576GA SED10132420GA SED09451343GA SED09451376GA SED09451345GA SED09491601GA SED10112270GA SED10122299GA SED09451344GA SED09451346GA SED09471494GA SED09511667GA SED09451342GA SED09491600GA SED09491603GA SED09471487GA 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 SED10071897GA SED10092028GA SED10021697GA SED10021714GA SED09451319GA SED09461407GA SED09461410GA SED09461412GA SED09461416GA SED09471431GA SED09471433GA SED09471440GA SED09471441GA SED09471442GA SED09441078GA SED09491529GA SED09461381GA SED09461382GA SED09461385GA SED09461389GA SED09461392GA SED09461398GA SED09431059GA SED09441180GA SED09441286GA SED09451311GA SED09451312GA SED09451313GA SED09451314GA SED09451315GA SED09451316GA SED09451318GA SED09461379GA SED09461380GA SED09461383GA SED09461384GA SED09461386GA SED09461387GA SED09461388GA SED09461390GA SED09461391GA SED09461393GA SED09461394GA SED09461396GA SED09461397GA SED09461400GA SED09461401GA SED09461403GA SED09461404GA SED09461405GA SED09461408GA SED09461409GA SED09461414GA SED09471448GA SED09471450GA SED09471452GA SED09471456GA SED09471457GA SED09491614GA SED09491615GA SED09491617GA SED09491619GA SED09421004GA SED09421006GA SED09421007GA SED09421009GA SED09421010GA SED09421011GA SED09431063GA SED09431064GA SED09431065GA SED09431067GA SED09431068GA SED09431070GA SED09431071GA SED09431074GA SED09441157GA SED09441158GA SED09441159GA SED09441160GA SED09441161GA SED09441162GA SED09441165GA SED09441168GA SED09441172GA SED09441173GA SED09441175GA SED09441177GA SED09441178GA SED09441186GA SED09441189GA SED09441195GA SED09441198GA SED09441199GA SED09441200GA SED09441201GA SED09441202GA SED09441203GA SED09441204GA SED09441206GA SED09441207GA SED09441208GA SED09441209GA SED09441210GA SED09441211GA SED09441212GA SED09441277GA SED09451351GA SED09451366GA SED09451367GA SED09451368GA SED09451370GA SED09451371GA SED09451372GA SED09451373GA SED09451374GA SED09451375GA SED09451377GA SED09451378GA SED09451322GA SED09471479GA SED09471483GA SED09491579GA SED09491590GA SED09491594GA SED09451353GA SED10041828GA SED10041829GA SED09390837GA SED09390851GA SED09390855GA SED09390858GA SED10021687GA SED10021726GA SED10021732GA SED10041837GA SED10041838GA SED10041841GA SED10041842GA SED10041846GA SED10041847GA SED10041849GA SED10041850GA SED10041851GA SED10041852GA SED10041855GA SED10041858GA SED10041860GA SED10041861GA SED10041864GA SED10071922GA SED10071924GA SED10112208GA SED10112209GA SED10112210GA SED10112214GA SED10112217GA SED10112218GA SED10112219GA SED10112221GA SED10112222GA SED10112223GA SED10112224GA SED10112225GA SED10112227GA SED10112229GA SED10112230GA SED10112231GA SED10112232GA SED10112234GA SED10112237GA SED10112238GA SED10112239GA SED10112241GA SED10112243GA SED10112244GA SED10112245GA SED09511639GA SED10041809GA SED10041816GA SED10041819GA SED10041827GA SED10041830GA SED10041831GA SED10061874GA SED09410975GA SED10132427GA SED09400926GA SED09400935GA SED09400936GA SED09400940GA SED09421012GA SED09421019GA SED09431025GA SED09431034GA SED09431036GA SED09431038GA SED09431039GA SED09431040GA SED09431043GA SED09431044GA SED09431056GA SED09431057GA SED10021702GA SED10021703GA SED10021709GA SED10021711GA SED09451347GA SED09431054GA SED09431055GA SED09431058GA SED09431060GA SED09441255GA SED09441257GA SED09441259GA SED09441261GA SED09441264GA SED09441265GA SED09441267GA SED09441268GA SED09441272GA SED09441273GA SED09441275GA SED09441280GA SED09441282GA SED09441288GA SED09441291GA SED09441294GA SED09451302GA SED09431033GA SED09451323GA SED09451326GA SED09451330GA SED09451331GA SED09451336GA SED09451338GA SED10061879GA SED09340627GA SED09340631GA SED09340650GA SED09340657GA SED09340658GA SED09420982GA SED09420983GA SED09420984GA SED09420991GA SED09420996GA SED09420999GA SED09421000GA SED09421002GA SED09400928GA SED10061875GA SED09400918GA SED09441260GA SED09461395GA SED09461417GA SED09461418GA SED09471420GA SED09471421GA SED09471423GA SED09471426GA SED09471430GA SED09471435GA SED09471443GA SED09471444GA SED09471445GA SED09471446GA SED09471447GA SED09441155GA SED09441156GA SED09441163GA SED09441164GA SED09441166GA SED09441167GA SED09441169GA SED09441170GA SED09441171GA SED09441174GA SED09441176GA SED09441184GA SED09441185GA SED09441187GA SED09441188GA SED09441190GA SED09441191GA SED09491521GA SED09491525GA SED09491539GA SED09491566GA SED09491568GA SED09491570GA SED09491571GA SED09491573GA SED09491574GA SED09431041GA SED09471471GA SED09471475GA SED09471492GA SED09471495GA SED09471498GA SED10021694GA SED10021712GA SED10021719GA SED10021728GA SED10021729GA SED10021731GA SED10021734GA SED10041812GA SED10041820GA SED10061876GA SED10061877GA SED10061885GA SED10061887GA SED10061888GA SED10061892GA SED10092045GA SED10102052GA SED10102056GA SED10112252GA SED10112253GA SED10112254GA SED10112255GA SED10112256GA SED10112262GA SED10112263GA SED10112265GA SED10112269GA SED10112272GA SED10112273GA SED10112274GA SED10112275GA SED10112276GA SED10112277GA SED10112278GA SED10112280GA SED10122282GA SED10122284GA SED10122290GA SED10122292GA SED10122295GA SED10122296GA SED10122305GA SED10122307GA SED10122309GA SED10122311GA SED10122313GA SED10122315GA SED10122317GA SED10122319GA SED10122333GA SED10122338GA SED10122339GA SED10122343GA SED10122344GA SED10122346GA SED10122350GA SED09280439GA SED09310485GA SED09310506GA SED09330579GA SED09330583GA SED09330599GA SED09330600GA SED09330602GA SED09330603GA SED09330604GA SED09340607GA SED09340625GA SED09340626GA SED09350666GA SED09350667GA SED09350674GA SED09350675GA SED09350693GA SED09350694GA SED09350696GA SED09350699GA SED09350700GA SED09350715GA SED09350717GA SED09350721GA SED09370732GA SED09370733GA SED09370740GA SED09400929GA SED09400930GA SED09400932GA SED09400939GA SED09400950GA SED09441256GA SED09441258GA SED09441287GA SED09441292GA SED09451308GA SED09451320GA SED09451325GA SED09451327GA SED09451334GA SED09421013GA SED09421017GA SED09441269GA SED09441289GA SED09451301GA SED09451307GA SED09451328GA SED09451329GA SED09451332GA SED09451335GA SED09451337GA SED10021685GA SED10021686GA SED10021689GA SED10021693GA SED10021695GA SED09310460GA SED09310465GA SED09340612GA SED09340613GA SED09340615GA SED09340624GA SED09340630GA SED09340633GA SED09340634GA SED09340636GA SED09340639GA SED09350716GA SED09370724GA SED09370728GA SED09370731GA SED09370735GA SED09370737GA SED09370745GA SED09370751GA SED09370794GA SED09370796GA SED09370797GA SED09370800GA SED09370801GA SED09471424GA SED09471427GA SED09471428GA SED09471436GA SED09471438GA SED09471439GA SED09370743GA SED09370823GA SED09370831GA SED09390848GA SED09400938GA SED09441262GA SED09441266GA SED09441271GA SED09441276GA SED09441278GA SED09441279GA SED09441284GA SED09441290GA SED09441293GA SED09451299GA SED09451306GA SED09451321GA SED09471485GA SED09471497GA SED09491586GA SED09511672GA SED09441263GA SED09441285GA SED09471419GA SED09310459GA SED09340608GA SED09350691GA SED09350695GA SED09350718GA SED09400952GA SED09370818GA SED09421015GA SED09421016GA SED09421021GA SED09431023GA SED09431037GA SED09431045GA SED09431046GA SED09431047GA SED09431048GA SED09431049GA SED09431050GA SED09431051GA SED09431052GA SED09431053GA SED09431062GA SED09431022GA SED09431024GA SED09431027GA SED09431028GA SED09431029GA SED09431031GA SED09441270GA SED09441274GA SED09441281GA SED09441283GA SED09461413GA SED09461415GA SED09471422GA SED09471425GA SED09471429GA SED09471434GA SED09471437GA SED10071940GA SED10112190GA SED10112198GA SED10112250GA SED10112251GA SED10112266GA SED10112279GA SED10122283GA SED10122301GA SED10142597GA SED10192736GA SED09511664GA SED09511665GA SED09451300GA SED09451309GA SED09451324GA SED09451310GA SED09471449GA SED09471454GA SED09471455GA SED09491530GA SED09491531GA SED09491532GA SED09491620GA SED09350698GA SED09350701GA SED09350712GA SED09350714GA SED09350719GA SED09350720GA SED09340659GA SED09350668GA SED09350669GA SED09350670GA SED09350671GA SED09350672GA SED09350673GA SED09350676GA SED09350677GA SED09350690GA SED09350692GA SED09350697GA SED09350713GA SED09370736GA SED09491606GA SED09511669GA SED09491632GA SED09511648GA SED09511659GA SED09421018GA SED09421020GA SED09431026GA SED09431030GA SED09431032GA SED09431035GA SED09451304GA SED09451305GA SED09441196GA SED09511658GA SED09511660GA SED09511661GA SED09511662GA SED09511663GA SED09511666GA SED09511668GA SED09511677GA SED09511678GA SED10021690GA SED10021692GA SED09370742GA SED09370807GA SED09370808GA SED09370810GA SED09370816GA SED09390892GA SED09390867GA SED09390872GA SED09400906GA SED09471473GA SED10021715GA SED10021720GA SED10041824GA SED10112150GA SED10112155GA SED10112156GA SED10112165GA SED10112173GA SED10112199GA SED10122287GA SED10122288GA SED10122291GA SED10122297GA SED10122314GA SED10122325GA SED10122326GA SED10122331GA SED10122332GA SED10122334GA SED10122335GA SED10132391GA and SED10132417GA
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, CO, FL, GA, KY, LA, MA, MI, NE, NJ, NY, NC, OH, OR, PA, TX VA, and WI, Foreign: UNITED KINGDOM, TURKEY, SWITZERLAND, SPAIN , SLOVENIA, SINGAPORE, SAUDI ARABIA, PORTUGAL NETHERLAND, ITALY, GERMANY, FRANCE,FINLAND, DENMARK, CZECH REPUBLIC, BELGIUM, AUSTRIA, and AUSTRALIA.
  • Product Description
    CARESCAPE MONITOR B850 || Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility.
  • Manufacturer
    GE Healthcare, LLC
  • 1 Event

Manufacturer

GE Healthcare, LLC
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

Device Recall CARESCAPE Monitor B850, B650 or B450
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US nationwide, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, REUNION, QATAR, PORTUGAL, POLAND, PHILIPPINEs, PARAGUAY, PANAMA, NORWAY, NEW ZEALAND, NETHERLANDS, MYANMAR, MOROCCO, MEXICO, MALAYSIA, LITHUANIA, LEBANON, LATVIA, JORDAN, JAPAN, JAMAICA, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, ICELAND, HUNGARY, GREECE, GIBRALTAR, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, ECUADOR, DENMARK, CZECH REPUBLIC, CYPRUS, CROATIA, CHILE, BRUNEI, BERMUDA, BELGIUM, BANGLADESH, AUSTRIA, AUSTRALIA.
  • Product Description
    GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
  • Manufacturer
    GE Healthcare, LLC
Device Recall CARESCAPE Monitor B850
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, AZ, AR, CA, CO, CT, FL,GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA,PR, SC, TN,TX, UT, VA, WA, WV, WI. UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TUNISIA, THAILAND, SWITZERLAND, SWEDEN SLOVENIA, SLOVAKIA, SPAIN, SINGAPORE, SAUDI ARABIA, QATAR, PORTUGAL POLAND, NORWAY, NORTH KOREA, NEW ZEALAND, NETHERLANDS, MALTA, MALAYSIA, LITHUANIA, LEBANON, KUWAIT, ITALY, ISRAEL, IRELAND, INDIA, ICELAND, HONG KONG, GERMANY, FRANCE, FINLAND, DENMARK, ESTONIA, CZECH REPUBLIC, BELGIUM BAHRAIN, COLOMBIA, CHILE CANADA, BRAZIL, AUSTRIA, AUSTRALIA.
  • Product Description
    GE Healthcare, CARESCAPE Monitor B850 || The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including EGG, ST segment, arrhythmia detection, EGG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (C02, 02, N20 and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 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. The CARESCAPE Monitor B650 is not intended for use during MRI.
  • Manufacturer
    GE Healthcare, LLC