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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81075

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 04, 2018
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
GE Healthcare Finland Oy

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B450 is indicated for monitoring of: -hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation, -Respiratory (impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), and spirometry) -neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

Z-0095-2019
Recall number
Z-0095-2019
Initiated
September 04, 2018
Classification
Class II
Status
Ongoing
Recalling firm
GE Healthcare Finland Oy
Quantity
59,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.

Code information

Serial numbers: No UDI: SJA15150092HA SJA15150100HA SJA15150124HA SJA15150125HA SJA15150126HA SJA15150127HA SJA15150128HA SJA15150139HA SJA15170033HA SJA15170079HA SJA15170081HA SJA15170085HA SJA15170086HA SJA15170087HA SJA15170088HA SJA15170089HA SJA15170090HA SJA15170091HA SNE16060190HA SNE16110218HA SJA14127613HA SJA14127614HA SJA15262026HA SJA15262173HA SJA15272036HA SJA15282008HA SJA15282009HA SJA15282010HA SJA15282014HA SJA15282015HA SJA15282016HA SJA15282017HA SJA15282019HA SJA15282022HA SJA15282024HA SJA15282043HA SJA15282044HA SJA15282048HA SJA15282051HA SJA15282054HA SJA15282055HA SJA15282059HA SJA15282060HA SJA15282063HA SJA15282065HA SJA15282118HA SJA15282122HA SJA15282125HA SJA15282128HA SJA15282129HA SJA15282131HA SJA15282134HA SJA15282135HA SJA15282141HA SJA15282149HA SJA15382048HA SJA14437335HA SJA14437337HA SJA14127619HA SJA14127621HA SJA14127622HA SJA14127623HA SJA14127624HA SJA14127626HA SJA14392398HA SJA14392402HA SJA14192489HR SJA14302513HR SJA15401023HR SJA15170060HA SJA15170127HA SJA15170128HA SJA15170129HA SJA15170130HA SJA15170137HA SJA15292063HA SJA14473730HA SNE15480016HA SNE15480017HA SNE15480019HA SNE15511032HA SJA15342151HA SJA15342152HA SJA15252097HA SJA15252142HA SJA15252143HA SJA15252144HA SJA15252149HA SJA15252150HA SJA15252151HA SJA15262060HA SJA15262061HA SJA15262062HA SJA15262063HA SJA15262064HA SJA15262068HA SJA15262069HA SJA15262070HA SJA15452019HA SNE15431001HA SNE16010064HA SNE16010070HA SNE16010071HA SNE16010078HA SNE16010079HA SNE16010080HA SJA15262004HA SJA15262005HA SJA14403421HA SJA15101137HA SNE16110060HA SNE16110063HA SNE16110065HA SNE16110066HA SJA15262006HA SNE16080111HA SNE16080112HA SNE16080113HA SNE16080114HA SNE16080115HA SNE16080116HA SNE16080117HA SNE16080118HA SNE16080119HA SNE16080121HA SNE16050129HA SNE16050131HA SNE16120029HR SNE16120040HR SNE15520017HA SNE15520018HA SNE15520019HA SNE15520020HA SNE15520022HA SNE15531045HA SNE15531046HA SNE16010075HA SNE16010076HA SNE16010077HA SNE15520036HA SNE15520079HA SNE15520080HA SNE16080202HA SNE16080203HA SNE16080204HA SNE16080206HA SNE16080207HA SNE16090021HA SNE16090022HA SNE16090024HA SNE16090025HA SNE16090027HA SNE16090029HA SNE16090031HA SNE16090032HA SNE16130019HA SNE16130020HA SNE16130023HA SNE16130024HA SJA14138552HA SJA14138553HA SJA14138555HA SJA14138558HA SJA15120117HA SJA15120146HA SJA15120147HA SJA15120148HA SJA15120149HA SJA15120150HA SJA15120151HA SJA15120152HA SJA15120154HA SJA15120155HA SJA15120156HA SJA15120157HA SJA15120161HA SJA15120164HA SJA15120165HA SJA15120166HA SJA15120168HA SJA15140138HA SJA15140139HA SJA15140140HA SJA15140141HA SJA15140145HA SJA15140146HA SJA15140147HA SJA15140148HA SJA15101204HA SJA15101207HA SJA15101221HA SJA15101224HA SJA15101235HA SJA15101240HA SJA15101243HA SJA15121009HA SJA15044565HA SJA15044566HA SJA15044567HA SJA15044569HA SJA15044571HA SJA15101292HA SJA15101293HA SJA15112630HA SJA15112631HA SJA15112632HA SJA15112633HA SJA15112635HA SJA15112636HA SJA15112637HA SJA15112638HA SJA15112639HA SJA15112640HA SJA15170076HA SJA15066575HA SJA15066586HA SJA15066599HA SJA15066600HA SNE16121015HA SJA13507992HR SJA14415427HR SNE16191082HR SJA15222023HA SNE16090200HA SJA14358266HA SJA14358267HA SJA14379900HA SJA14379901HA SJA14472381HA SJA15302035HA SJA15302041HA SJA14403455HA SJA14403456HA SJA15031768HA SJA15031818HA SJA15031819HA SJA15033243HA SJA15033244HA SJA15033245HA SJA15066593HA SJA15090664HA SJA15090665HA SJA15090675HA SNE15450027HA SNE15450028HA SNE15450029HA SJA14460951HA SJA14460973HA SNE17251032HA SJA15382323HA SJA14414517HA SJA15020681HA SJA15322125HA SJA15322131HA SJA15332114HA SJA15332124HA SJA15332138HA SJA15332139HA SJA15332141HA SJA15332142HA SJA15332143HA SJA15332144HA SJA15332145HA SJA15332149HA SJA15332150HA SJA15332151HA SJA14291680HA SJA15171001HA SJA15171002HA SJA15171003HA SJA15171005HA SJA15171006HA SJA15291004HA SNE15511001HA SNE15511004HA SNE15511008HA SNE15511014HA SNE16021001HA SNE16021002HA SJA13507985HA SJA13508793HA SJA13508794HA SJA13508795HA SJA13019537HA SJA13508792HA SJA13508796HA SJA13508797HA SJA14314410HA SNE16110126HA SNE15490001HA SNE15490034HA SNE15490070HA SNE15520077HA SNE15520078HA SNE15520088HA SNE15520089HA SNE15520090HA SJA14459942HA SJA14507676HA SJA14507679HA SJA14507680HA SJA14507691HA SJA14507692HA SJA14507703HA SJA14507704HA SJA14519037HA SJA14519039HA SJA14519041HA SJA14519042HA SJA14519043HA SJA14519045HA SJA14519046HA SJA14519048HA SNE15511016HA SNE15531064HA SJA13519474HR SNE16181001HR SNE16181014HR SNE16181029HR SNE16181033HR SNE16181035HR SNE16181041HR SNE16181042HR SNE16181047HR SNE16181048HR SNE16181054HR SNE16181056HR SNE16181059HR SNE16181061HR SNE16181062HR SNE16181070HR SNE16191003HR SNE16191008HR SNE16191010HR SNE16191015HR SNE16191016HR SNE16191017HR SNE16191028HR SNE16191029HR SNE16191055HR SNE16191068HR SNE16191071HR SNE16191073HR SNE16191076HR SNE16191078HR SJA14381877HA SJA14381881HA SJA14381885HA SJA14392419HA SJA14392420HA SJA14392421HA SJA14392422HA SJA14392423HA SJA14392424HA SJA14392425HA SJA14392426HA SJA14392427HA SJA14392428HA SJA14392429HA SJA14392430HA SJA14392431HA SJA14392432HA SJA14392433HA SJA14203743HA SJA14203744HA SJA14381884HA SNE15531063HA SNE16031047HA SNE16031048HA SNE16036001HA SNE16010095HA SJA14325792HA SJA14325806HA SJA14325807HA SJA14325808HA SJA14325812HA SJA14357840HA SJA14357846HA SJA14357876HA SJA14357897HA SJA14357911HA SJA14357922HA SJA14357926HA SJA14358227HA SJA14358229HA SJA14358231HA SJA14358232HA SJA14358233HA SJA14358234HA SJA14358239HA SJA14358240HA SJA14358241HA SJA14358242HA SJA14358243HA SJA14358244HA SJA14358245HA SJA14358246HA SJA14358247HA SJA14358248HA SJA14358249HA SJA14358250HA SJA14358251HA SJA14358252HA SJA14358253HA SJA14358254HA SJA14358255HA SJA14358256HA SJA14368675HA SJA14368676HA SJA14280404HA SJA14368671HA SJA14368672HA SJA14368673HA SJA14368674HA SNE15511005HA SNE15511007HA SNE15511009HA SNE15511011HA SNE15511013HA SNE15511015HA SNE16100025HA SNE16100026HA SNE16100027HA SJA14235853HA SJA14279203HA SJA14279206HA SJA14279207HA SJA14279208HA SJA14279209HA SJA14279210HA SJA14279361HA SJA14279362HA SJA14279363HA SJA15422152HA SJA15422158HA SJA15422159HA SJA15422161HA SJA15422162HA SJA15422163HA SJA15422164HA SJA15422170HA SNE15500006HA SNE15500008HA SNE15500009HA SNE15500010HA SNE15500012HA SNE15500014HA SNE15501010HA SNE15501011HA SNE15501012HA SNE15501019HA SNE15501020HA SNE15501023HA SJA15150008HA SJA15150009HA SJA15150013HA SJA15150014HA SJA15402181HA SJA15402197HA SJA15402199HA SJA15412022HA SJA15412023HA SJA15412025HA SJA15412027HA SJA15412029HA SJA15412030HA SJA15412105HA SJA15130183HA SJA15140011HA SJA15140012HA SJA14368825HA SJA14379838HA SJA14448621HA SJA14449434HA SJA15191019HA SJA15201001HA SJA15201002HA SNE16080120HA SNE16080122HA SJA14302539HA SJA14302540HA SJA14302541HA SJA14302542HA SJA14302594HA SJA14302595HA SJA14302596HA SJA14302597HA SJA14302598HA SJA14302599HA SJA14302601HA SJA14302602HA SJA14302637HA SJA14484603HA SJA14484613HA SJA14484617HA SJA14484627HA SJA14484628HA SJA14484631HA SJA14484632HA SJA14484665HA SJA14484675HA SJA14484677HA SJA14495870HA SJA14495871HA SJA15055857HA SJA15055858HA SJA15055862HA SJA15055863HA SJA15055864HA SJA15055865HA SJA15055866HA SJA15055867HA SJA15055870HA SJA15055871HA SJA15055872HA SJA15055873HA SJA15211010HA SJA14507731HA SJA14507741HA SJA14182149HA SJA15262132HA SJA15262133HA SJA15262139HA SJA15391032HA SJA15391033HA SJA15391034HA SJA15391036HA SJA15401001HA SJA15401004HA SJA15442067HA SJA15442073HA SJA15442074HA SJA15442076HA SJA15442077HA SJA15442078HA SJA15442079HA SJA15442084HA SJA15442085HA SNE15461011HA SNE15461032HA SNE15461033HA SNE15490116HA SNE15490133HA SNE15500163HA SNE15510292HA SNE15520021HA SNE16010040HA SNE16030003HA SNE16050091HA SNE16050097HA SNE16050098HA SNE16050099HA SNE16050100HA SNE16101011HA SNE16101012HA SNE16101014HA SJA15381005HA SJA15381006HA SJA15382046HA SJA15382050HA SJA15382051HA SJA15382052HA SJA14450048HA SJA14450049HA SJA14302614HA SJA14302633HA SJA14302634HA SJA14302635HA SJA14302636HA SJA14302638HA SJA14302639HA SJA14302640HA SJA14302641HA SJA14302642HA SJA14313514HA SJA14313515HA SJA14313517HA SJA14313518HA SJA14313519HA SJA14313520HA SJA14313521HA SJA14313522HA SJA14313524HA SJA14313525HA SJA14313526HA SJA14313527HA SJA14313528HA SJA14313530HA SJA14313531HA SJA14313532HA SJA14313533HA SJA14313534HA SJA14313535HA SJA14313536HA SJA14313537HA SJA14313538HA SJA14313539HA SJA14313540HA SJA14313541HA SJA14313542HA SJA14313543HA SJA14313544HA SJA14313545HA SJA14313546HA SJA14313547HA SJA14313548HA SJA14313549HA SJA14313550HA SJA14313551HA SJA14313552HA SJA14313553HA SJA14313554HA SJA14313555HA SJA14313556HA SJA14313557HA SJA14313558HA SJA14313559HA SJA14313560HA SJA14313561HA SJA14313562HA SJA14314282HA SJA14314283HA SJA14314284HA SJA14314285HA SJA14314286HA SJA14314287HA SJA14314288HA SJA14314289HA SJA14314290HA SJA14314291HA SJA14314292HA SJA14314293HA SJA14314294HA SJA14314295HA SJA14314296HA SJA14314303HA SJA14314304HA SJA14314305HA SJA14314306HA SJA14314307HA SJA14314308HA SJA14314309HA SJA14314310HA SJA14314311HA SJA14314312HA SJA14314313HA SJA14314314HA SJA14314315HA SJA14314316HA SJA14314317HA SJA14314318HA SJA14314319HA SJA14314320HA SJA14314321HA SJA14314322HA SJA14314323HA SJA14314324HA SJA14314325HA SJA14314326HA SJA14314327HA SJA14314328HA SJA14314329HA SJA14314330HA SJA14314331HA SJA14314332HA SJA14314333HA SJA14314334HA SJA14314335HA SJA14314336HA SJA14314337HA SJA14314338HA SJA14314339HA SJA14314340HA SJA14314341HA SJA14314342HA SJA14314343HA SJA14314344HA SJA14314345HA SJA14314346HA SJA14314347HA SJA14314348HA SJA14314349HA SJA14314350HA SJA14314351HA SJA14314352HA SJA14314353HA SJA14314354HA SJA14314355HA SJA14314356HA SJA14314357HA SJA14314358HA SJA14314359HA SJA14314360HA SJA14314361HA SJA14314362HA SJA14314363HA SJA14314364HA SJA14314365HA SJA14314366HA SJA14314367HA SJA14314368HA SJA14314369HA SJA14314370HA SJA14314371HA SJA14314372HA SJA14314373HA SJA14314374HA SJA14314394HA SJA14314395HA SJA14484531HA SJA15222097HA SJA15222112HA SJA15222113HA SJA15222114HA SJA15222116HA SJA15222117HA SJA15222122HA SJA15222123HA SJA15222126HA SJA15272035HA SNE16020073HA SNE16020081HA SNE16040033HA SNE16040034HA SNE16040035HA SJA15352012HA SJA15352013HA SJA15352014HA SJA15352015HA SJA15352016HA SJA15352017HA SJA15352018HA SJA15352019HA SJA15352020HA SJA15352021HA SJA15352022HA SJA15352024HA SJA15352039HA SJA15352041HA SJA15352150HA SJA15352154HA SJA15362004HA SJA15362009HA SJA15362010HA SJA15362013HA SJA15362014HA SJA15362015HA SJA15362016HA SJA15362017HA SJA15362018HA SJA15362019HA SJA15362020HA SJA15362022HA SJA15362023HA SJA15362024HA SJA15362040HA SJA15362116HA SJA15362146HA SJA15362147HA SJA15362149HA SJA15362150HA SJA15362231HA SJA15372086HA SJA15372108HA SJA15372114HA SJA15372116HA SJA15372120HA SJA15372121HA SJA15372122HA SJA15372123HA SJA15372124HA SJA15372126HA SJA15372130HA SJA15382180HA SJA15382181HA SJA15382184HA SJA15382185HA SJA15382190HA SJA15382252HA SJA15382253HA SJA15382279HA SJA15382280HA SJA15382281HA SJA15382282HA SJA15382283HA SJA15382284HA SJA15382289HA SJA15382290HA SNE16051024HA SNE16061001HA SNE16061002HA SNE16061003HA SNE16061004HA SNE16061006HA SJA15187909HA SJA15222180HA SJA15401009HA SJA15401050HA SJA15411015HA SJA15411016HA SJA15411019HA SJA15411020HA SJA15411021HA SJA15411023HA SJA15411024HA SJA15421002HA SJA15421003HA SJA15421004HA SJA15421005HA SJA15421006HA SJA15421007HA SJA15421008HA SJA15421009HA SJA15421010HA SJA15421011HA SJA15421013HA SJA15421014HA SJA15421015HA SJA15421016HA SJA15421017HA SJA15421019HA SJA15421020HA SJA15421021HA SJA15422176HA SJA15422177HA SJA15422234HA SJA15422235HA SJA15422237HA SJA13019541HA SJA13019542HA SJA13019551HA SJA14019583HA SJA14019587HA SJA14019589HA SJA14019591HA SJA14019594HA SJA14019596HA SJA14019598HA SJA14392366HA SJA15031738HA SJA15031753HA SJA15031776HA SJA15031777HA SJA15031778HA SJA15031779HA SJA15031780HA SJA15031781HA SJA15031782HA SJA15031783HA SJA15031784HA SJA15031786HA SJA15031791HA SJA15088401HA SJA15088402HA SJA15088403HA SJA15088404HA SJA15088405HA SJA15088408HA SJA15088409HA SJA15088413HA SJA15088420HA SJA15130140HA SJA15362021HA SJA15362029HA SJA15362049HA SJA15362050HA SJA15362051HA SJA15362052HA SJA15362053HA SJA15362054HA SJA15362055HA SJA15362056HA SJA15362057HA SJA15362059HA SJA15362060HA SJA15362063HA SJA15362106HA SJA15362112HA SJA15362113HA SJA15362114HA SJA15362115HA SJA15362164HA SNE15470056HA SNE16080028HA SNE16080031HA SNE16080034HA SJA14302519HR SNE15461048HR SJA15160046HA SJA15170025HA SJA15170037HA SJA15170038HA SJA15170039HA SJA15170040HA SJA15170041HA SJA15170044HA SJA15170080HA SJA15382315HA SJA15382316HA SJA15382317HA SJA15382318HA SJA15382319HA SNE16060035HA SNE16060040HA SNE16060041HA SNE16060042HA SNE16060044HA SJA15332265HA SNE15461005HA SNE15461037HA SJA14426674HA SJA14426675HA SNE15511075HA SNE16041041HA SNE16041046HA SNE16051014HA SNE16061009HA SNE16071001HA SNE16071003HA SNE16071004HA SJA14370478HA SJA14370479HA SJA14370481HA SJA14379942HA SJA14379943HA SJA15130154HA SJA15322024HA SJA15322025HA SJA15322028HA SJA15322029HA SJA15322030HA SJA15322031HA SJA15322034HA SJA15322037HA SJA15322038HA SJA15322039HA SJA15322040HA SJA15322041HA SJA15322042HA SJA15322043HA SJA15322044HA SJA15322045HA SJA15322047HA SJA15322050HA SJA15322052HA SJA15322130HA SJA15322153HA SJA15322165HA SJA15322167HA SJA15322168HA SJA15322169HA SJA15322170HA SJA15322171HA SJA15322173HA SJA15322174HA SJA15322175HA SJA15322177HA SJA15322178HA SJA15322179HA SJA15322180HA SJA15322181HA SJA15322182HA SJA15322183HA SJA15322184HA SJA15322185HA SJA15322186HA SJA15322187HA SJA15322189HA SJA15322190HA SJA15322191HA SJA15322192HA SJA15322195HA SJA15322196HA SJA15322197HA SJA15322199HA SJA15322200HA SJA15322202HA SJA15322205HA SJA15322206HA SJA15322207HA SJA15322208HA SJA15322210HA SJA15322211HA SJA15322212HA SJA15322213HA SJA15322214HA SJA15322215HA SJA15322218HA SNE15510138HA SNE15510150HA SJA15272108HA SJA15282097HA SJA15282116HA SJA15282117HA SJA15282120HA SJA15282121HA SJA15282127HA SJA15282136HA SJA15282138HA SJA15140063HA SJA15140122HA SJA15140123HA SJA15140124HA SJA15140125HA SJA15140126HA SJA15140127HA SJA15140128HA SJA15140130HA SJA15140131HA SJA15140132HA SJA15140133HA SJA15140134HA SJA15140135HA SJA15140136HA SJA15140137HA SJA15140142HA SJA15140143HA SJA15140150HA SJA15140151HA SJA15140152HA SJA15140153HA SJA15140154HA SJA15262114HA SJA15262120HA SJA15262121HA SJA15262122HA SJA15262123HA SJA15262124HA SJA15262125HA SJA15262126HA SJA15262127HA SJA15262128HA SJA15262129HA SJA15262130HA SJA15262131HA SJA15262137HA SJA15282140HA SJA15282143HA SJA15282144HA SJA15282145HA SJA15282148HA SJA15282151HA SJA15282153HA SJA15292112HA SJA15292113HA SJA15292116HA SJA15292122HA SJA15342129HA SNE15510122HA SNE15510123HA SNE15510191HA SNE15510197HA SNE15510198HA SNE15510199HA SNE15510200HA SNE15510201HA SNE15510202HA SNE15510267HA SNE15510268HA SNE15510269HA SNE15510270HA SNE15510271HA SNE15510272HA SNE15510276HA SNE15510277HA SNE15510279HA SNE15510282HA SNE15510314HA SNE15510315HA SNE15510316HA SNE15510319HA SNE15510320HA SNE15510321HA SNE15510323HA SNE15510324HA SNE15510325HA SNE15510326HA SNE15510327HA SNE16110192HA SNE16110213HA SNE16110227HA SNE16110232HA SNE16110382HA SNE16110383HA SNE16110384HA SNE16120001HA SNE16120197HA SNE16120198HA SNE16120199HA SNE16120200HA SJA14280388HA SJA14280405HA SJA14280406HA SJA14280407HA SJA14280408HA SJA14379914HA SJA14379915HA SJA14379921HA SJA14379922HA SJA14379923HA SJA14379924HA SJA14379926HA SJA14379927HA SJA14379928HA SJA14379929HA SJA14379931HA SJA14379932HA SJA14379933HA SJA14379934HA SJA14379935HA SJA14379944HA SJA14379946HA SJA15352075HA SJA15352095HA SJA15362031HA SJA15362033HA SJA15362034HA SJA15362035HA SJA15362037HA SJA15362038HA SJA15362039HA SJA15362041HA SJA15362042HA SJA15362043HA SJA15362044HA SJA15362045HA SJA15362046HA SJA15362047HA SJA15362048HA SJA15362058HA SJA15362075HA SJA15362076HA SJA15362077HA SJA15362078HA SJA15362080HA SJA15362081HA SJA15362082HA SJA15362084HA SJA15362090HA SJA15362093HA SJA15362094HA SJA15362095HA SJA15362096HA SJA15362098HA SJA15362100HA SJA15362102HA SJA15362117HA SJA15362118HA SJA15362119HA SJA15362120HA SJA15362121HA SJA15362123HA SJA15362124HA SJA15362125HA SJA15362126HA SJA15362127HA SJA15362128HA SJA15362130HA SJA15362132HA SJA15362133HA SJA15362134HA SJA15362136HA SJA15362137HA SJA15362138HA SJA15362139HA SJA15362140HA SJA15362141HA SJA15362142HA SJA15362143HA SJA15362144HA SJA15362145HA SJA15362152HA SJA15362154HA SJA15362155HA SJA15362156HA SJA15362157HA SJA15362158HA SJA15362160HA SJA15362161HA SJA15362162HA SJA15362163HA SJA15362188HA SJA15362189HA SJA15362190HA SJA15362191HA SJA15362192HA SJA15362193HA SJA15362194HA SJA15362195HA SJA15362196HA SJA15362197HA SJA15362198HA SJA15362199HA SJA15362200HA SJA15362201HA SJA15362202HA SJA15362203HA SJA15362204HA SJA15362205HA SJA15362206HA SJA15362207HA SJA15362208HA SJA15362209HA SJA15362210HA SJA15362211HA SJA15362212HA SJA15362213HA SJA15362241HA SNE16010001HA SNE16010002HA SNE16010003HA SNE16010004HA SNE16010007HA SNE16010008HA SNE16010017HA SNE16010020HA SNE16010021HA SNE16010022HA SNE16010024HA SJA13508795HR SJA13508797HR SJA14105920HR SJA14127605HR SJA14128051HR SJA14128064HR SJA14138536HR SJA15077569HA SJA15077570HA SJA15077573HA SJA15077574HA SJA15077578HA SJA15031769HA SJA15031704HA SJA15031705HA SJA15130201HA SJA15130202HA SJA15130203HA SJA14495874HA SJA14495875HA SJA14495876HA SJA14495877HA SJA15101269HA SJA15242026HA SJA15242133HA SJA15242136HA SJA15242137HA SJA15242138HA SJA15242139HA SJA15242141HA SJA15242142HA SJA15242143HA SJA15242146HA SJA15242147HA SJA15242148HA SJA15242149HA SJA15242150HA SJA15242151HA SJA15242152HA SJA15242155HA SJA15242156HA SJA15242159HA SJA14368858HA SJA14368878HA SJA14379823HA SJA14379824HA SJA14379825HA SNE15460013HA SNE15460014HA SNE15460016HA SNE15460019HA SNE15460020HA SNE15460022HA SNE15460023HA SNE15460024HA SNE15460025HA SJA15211004HA SJA15211007HA SJA15212196HA SJA14403451HA SJA14403512HA SJA14414521HA SJA14414525HA SJA14268634HA SJA14268646HA SJA14268647HA SJA14268648HA SJA14268649HA SJA14268650HA SJA14279181HA SJA14279182HA SJA14279183HA SJA14279184HA SJA14279185HA SJA14279186HA SJA14279187HA SJA14279188HA SJA14279189HA SJA14279190HA SJA14279191HA SJA14279192HA SJA14279193HA SJA14279194HA SJA14279195HA SJA14279196HA SJA14279197HA SJA14279198HA SJA15190086HA SJA15202006HA SJA15202048HA SJA15202049HA SJA15202050HA SJA15202053HA SJA15262084HA SJA15282004HA SNE16051004HA SNE16051006HA SNE16051009HA SNE16051010HA SNE16051011HA SNE16051013HA SNE16080123HA SNE16080124HA SNE16080134HA SNE16080190HA SNE16080197HA SNE16080201HA SJA14437429HA SJA14437435HA SJA14448539HA SJA14448540HA SJA14448541HA SJA14448542HA SJA14448543HA SJA14448544HA SJA14448545HA SJA14448546HA SJA14448547HA SJA14448548HA SJA14448550HA SJA14448551HA SJA14448560HA SJA14448569HA SJA14448578HA SJA14448580HA SJA14448583HA SJA14448584HA SJA14448587HA SJA14448588HA SJA14448589HA SJA14448590HA SJA14448591HA SJA14448593HA SJA14448595HA SJA14448599HA SJA14448712HA SJA14449734HA SJA15054938HA SJA15054939HA SJA15054952HA SJA15054954HA SJA15054958HA SJA15090082HA SNE15460074HA SNE15460092HA SNE15460093HA SNE15460096HA SNE15460118HA SNE15460193HA SNE15460195HA SNE15460196HA SNE15460203HA SNE15460205HA SNE15460207HA SNE15460208HA SNE15460218HA SNE15460220HA SNE15460225HA SNE15460226HA SNE15460227HA SNE15460228HA SNE15460229HA SNE15460230HA SNE15460231HA SNE15460232HA SNE15460233HA SNE15460234HA SNE15460235HA SNE15460236HA SNE15460237HA SNE15460238HA SNE15460239HA SNE15460240HA SNE15460241HA SNE15460242HA SNE15460243HA SNE15460244HA SNE15460245HA SNE15460246HA SNE15460247HA SNE15460248HA SNE15460249HA SNE15470127HA SNE15470129HA SNE16121001HA SNE16121002HA SNE16121003HA SNE16121008HA SNE16121009HA SNE16121010HA SNE16121011HA SNE16121012HA SJA15066501HA SJA15066502HA SJA15101037HA SJA15101038HA SJA15101048HA SJA15101049HA SJA15101050HA SJA15101051HA SJA15101052HA SJA15101053HA SJA15101067HA SJA15101068HA SJA15101069HA SJA15101070HA SJA15101071HA SJA15101072HA SJA15101073HA SJA15101074HA SJA15101075HA SJA15101076HA SJA15101077HA SJA15101078HA SJA15101091HA SJA15101092HA SJA15101093HA SJA15101094HA SJA15101095HA SJA15101096HA SJA15101098HA SJA15101099HA SJA15101100HA SJA15101101HA SJA15101102HA SJA15101103HA SJA15101104HA SJA15101105HA SJA15101106HA SJA15101107HA SJA15101108HA SJA15101109HA SJA15101110HA SNE15520034HR SNE16230064HR SJA15121006HA SJA15121013HA SJA15130040HA SJA15130053HA SJA15130061HA SJA15130062HA SJA15130063HA SJA15130064HA SJA15130065HA SJA15130067HA SJA15130069HA SJA15130070HA SJA15130071HA SJA15130072HA SJA15130073HA SJA15130077HA SJA15130078HA SJA15190174HA SJA15201003HA SJA15262078HA SJA15262079HA SJA15262080HA SJA15262081HA SJA15066606HA SJA15066607HA SJA15066608HA SJA15077537HA SJA15077649HA SJA15077659HA SJA15077664HA SJA15077665HA SJA15077667HA SJA15077668HA SJA15077669HA SJA15077670HA SJA15077671HA SJA15077673HA SJA15077677HA SJA15077678HA SJA15077679HA SJA15077680HA SJA15077681HA SJA15077682HA SJA15077688HA SJA15088367HA SJA15088368HA SJA15088369HA SJA15088370HA SJA15088371HA SJA15088372HA SJA15088373HA SJA15088374HA SJA15088410HA SJA15088411HA SJA15190087HA SJA15190160HA SJA15190161HA SJA15190170HA SJA15190171HA SJA15190173HA SJA15190175HA SJA15190177HA SJA15302003HA SJA15302004HA SJA15302005HA SJA15302007HA SJA15302013HA SJA15302014HA SJA14325149HA SJA14325157HA SJA14325166HA SJA14325167HA SJA15222012HA SJA15222103HA SJA15066504HA SJA15066505HA SJA15066506HA SJA15066507HA SJA15066508HA SJA15066509HA SJA15391042HA SJA15391044HA SJA15391045HA SJA15391046HA SJA15031727HA SJA15031728HA SJA15222022HA SJA15222029HA SJA15222030HA SJA13519471HR SJA14128044HR SJA14302495HR SJA14415430HR SJA15171009HR SJA15391051HR SNE15511051HR SNE15531025HR SNE15531035HR SNE15531039HR SNE16011001HR SNE16031008HR SNE15510094HA SNE15510095HA SNE15510096HA SNE15510103HA SNE15510104HA SNE15510105HA SNE15510110HA SNE15510112HA SNE15510114HA SNE15510124HA SNE16281004HR SNE16281020HR SNE16281026HR SNE16281028HR SNE16281032HR SJA15362252HA SJA15362253HA SJA15362257HA SJA15362262HA SJA15362263HA SJA15362264HA SNE16110176HA SNE16110181HA SNE16121007HA SNE16121017HA SJA14246433HA SJA14415102HA SNE16080187HA SJA15180046HA SJA15190121HA SJA15190129HA SJA15190130HA SJA15392080HA SJA15402046HA SJA15402049HA SJA15402050HA SJA15402052HA SJA15402053HA SJA15402054HA SJA15402071HA SJA15402072HA SJA15402073HA SJA15402075HA SJA15402077HA SJA15402078HA SJA15402079HA SJA15402080HA SJA15402081HA SJA15402122HA SJA15402123HA SJA15402138HA SJA15402144HA SJA15402146HA SJA15402147HA SJA15402150HA SJA15402151HA SJA15402152HA SJA15402153HA SJA15402154HA SJA15402155HA SJA15402156HA SJA14484619HA SJA14484626HA SJA14484669HA SJA14484670HA SJA14484671HA SJA14484674HA SJA14484678HA SJA14484679HA SJA14484680HA SJA14484681HA SJA14484682HA SJA14484683HA SJA14484684HA SJA14484685HA SJA14484686HA SJA14484688HA SJA14484689HA SJA14484690HA SJA14484691HA SJA14484692HA SJA14484693HA SJA14484694HA SJA14484695HA SJA14484696HA SJA14484697HA SJA14484699HA SNE16070142HA SJA15371001HA SJA13519475HR SJA14302502HR SJA14302530HR SJA15151006HR SJA15391027HR SJA15401024HR SJA14461968HA SJA14461972HA SJA14461984HA SJA14461985HA SJA14461987HA SJA14472339HA SJA14472340HA SJA14472341HA SJA14472342HA SJA14472343HA SJA14472392HA SJA14472393HA SJA14472405HA SJA14472406HA SJA14472407HA SJA14472408HA SJA14472409HA SJA14472410HA SJA14472411HA SJA14472412HA SJA14472413HA SJA15160024HA SJA15160029HA SJA15160030HA SJA15160031HA SJA15160032HA SJA15160033HA SJA15160034HA SJA15160038HA SJA15160039HA SJA15160040HA SJA15160041HA SJA15160047HA SJA15232202HA SJA15242024HA SJA15242036HA SJA15242153HA SJA15242157HA SJA15242158HA SJA15242160HA SJA15242161HA SJA15242163HA SJA15242164HA SJA15242165HA SJA15242166HA SJA15242171HA SJA15282195HA SJA15292015HA SJA15272074HA SJA14381144HA SNE16100178HA SNE16100198HA SNE16100200HA SNE16110106HA SJA15130116HA SJA15130117HA SJA15130118HA SJA15140021HA SJA14149166HA SJA15422175HA SJA15422190HA SJA15422191HA SJA15422192HA SJA15088362HA SJA15088363HA SJA15088364HA SJA15088365HA SJA15088366HA SJA15088388HA SJA15088389HA SJA15088390HA SJA15088391HA SJA15088392HA SJA15088393HA SJA15088394HA SJA15088396HA SJA15088397HA SJA15088398HA SJA15088400HA SJA15088406HA SJA15232144HA SJA15242067HA SJA15242068HA SJA15242069HA SJA15242070HA SJA15242071HA SJA15242072HA SJA15242073HA SJA15242075HA SJA15242076HA SJA15242077HA SJA15242079HA SJA15242080HA SJA15242081HA SJA15242082HA SJA15242084HA SJA15242085HA SJA15242086HA SJA15242087HA SJA15242088HA SJA15242089HA SJA15242090HA SJA15242091HA SJA15242093HA SJA15242094HA SJA15242095HA SJA15242096HA SJA15242097HA SJA15242098HA SJA15242099HA SJA15242100HA SJA15242101HA SJA15242102HA SJA15242103HA SJA15242105HA SJA15242106HA SJA15242107HA SJA15242108HA SJA15242109HA SJA15242110HA SJA15242111HA SJA15242112HA SJA15242114HA SJA15242115HA SJA15242116HA SJA15242117HA SJA15242118HA SNE16100285HA SNE16100286HA SNE16100287HA SNE16100295HA SJA15402086HA SJA15402088HA SJA15402095HA SJA15271013HA SJA15452034HA SJA15452035HA SJA15452038HA SJA15452039HA SJA15452040HA SJA15452114HA SJA15452115HA SJA15452116HA SJA15452117HA SJA15452118HA SJA15452119HA SJA15452120HA SJA15452121HA SJA15452122HA SJA15452123HA SJA15452124HA SJA15452125HA SJA15452131HA SNE15530021HA SNE16020018HA SNE16030075HA SNE16030081HA SNE16030104HA SNE16030105HA SNE16030106HA SNE16030107HA SNE16030108HA SNE16030109HA SNE16030110HA SNE16030112HA SNE16030114HA SNE15480126HA SNE15480127HA SJA15362255HA SJA15362256HA SJA15033254HA SJA15120008HA SJA15120009HA SJA15120010HA SJA15170061HA SJA14507671HA SJA14507672HA SJA15332326HA SJA15332333HA SJA15392188HA SJA15352070HA SJA15362061HA SJA15362062HA SJA15362069HA SJA14357842HA SNE16061007HA SNE16061008HA SJA14392415HA SJA15282006HA SNE15450055HA SNE15460002HA SNE15460003HA SNE15460004HA SNE15460005HA SNE15460007HA SNE15460008HA SNE15460009HA SNE15460010HA SNE15460011HA SNE15460012HA SNE15460030HA SNE15460032HA SNE15460033HA SNE15460034HA SNE15460035HA SNE15460037HA SNE15460038HA SNE15460164HA SNE15460165HA SNE15460166HA SNE15460167HA SNE15460198HA SNE15500081HA SNE15500083HA SNE15500084HA SNE15500085HA SNE15500089HA SNE15500090HA SNE15500091HA SNE15500092HA SNE15500093HA SNE15500094HA SNE15500130HA SNE15500132HA SJA15088511HA SJA15088514HA SJA15088517HA SJA15088518HA SJA15088520HA SJA15088521HA SJA15088522HA SJA15088523HA SJA15088524HA SJA15088525HA SJA15088526HA SJA15088527HA SJA15088528HA SJA15088529HA SJA15088533HA SJA15088534HA SJA15382331HA SJA15382334HA SJA15382335HA SJA15382336HA SJA15382337HA SJA15382338HA SJA15382339HA SJA15382346HA SJA14370494HA SJA14370495HA SJA14370496HA SJA14370497HA SJA14370500HA SJA14370501HA SJA14370502HA SJA14370503HA SJA14370504HA SJA14370505HA SJA14370506HA SJA14370507HA SJA14370508HA SJA14370509HA SJA14370510HA SJA14370511HA SJA14370512HA SJA14370513HA SJA14370524HA SJA14370525HA SJA14370526HA SJA14370527HA SJA14370528HA SJA14370529HA SJA14370530HA SJA14370531HA SJA14370536HA SJA14370537HA SJA14379843HA SJA14379882HA SJA14381870HA SJA14392410HA SJA14403423HA SJA14403424HA SJA14403425HA SJA14403426HA SJA14403427HA SJA14437380HA SJA14437381HA SJA14437382HA SJA14437383HA SJA14448675HA SJA14448676HA SJA14448678HA SJA14448685HA SJA14448686HA SJA14448687HA SJA14459927HA SJA14460920HA SJA14460923HA SJA14460924HA SJA14460928HA SJA14461948HA SJA14472374HA SJA14472375HA SJA14473687HA SJA14473688HA SJA14484614HA SJA14484622HA SJA14484623HA SJA14484630HA SJA14484633HA SJA14484634HA SJA14484643HA SJA14484649HA SJA14495856HA SJA14495857HA SJA14495858HA SJA14495859HA SJA14495860HA SJA14495861HA SJA14495862HA SJA14495863HA SJA14495864HA SJA14495865HA SJA14495866HA SJA14495867HA SJA14495868HA SJA14495869HA SJA14495872HA SJA14495873HA SJA14495883HA SJA14495884HA SJA14507582HA SJA15292016HA SJA14171407HA SJA14414547HA SJA14415075HA SJA14415077HA SJA14415080HA SJA14415081HA SJA14415082HA SJA14415084HA SJA14415085HA SJA14415086HA SJA14415088HA SJA14415089HA SJA14415090HA SJA14415091HA SJA14415092HA SJA14415094HA SJA14450024HA SJA14450031HA SJA14450033HA SJA14450039HA SJA14450045HA SJA14450047HA SJA14450065HA SJA14450067HA SJA14472333HA SJA14472344HA SJA14472351HA SJA14472352HA SJA14472353HA SJA14472354HA SJA14472355HA SJA14472356HA SJA14472357HA SJA14472358HA SJA14472359HA SJA14472360HA SJA14472362HA SJA14472363HA SJA14472364HA SJA14472445HA SJA14472446HA SJA14472447HA SJA14472448HA SJA14472449HA SJA14472450HA SJA14472506HA SJA14472510HA SJA14473710HA SJA14473711HA SJA14473712HA SJA14473713HA SJA14473714HA SJA14473715HA SJA14473716HA SJA14473717HA SJA14473718HA SJA14473723HA SJA14473724HA SJA14473725HA SJA14473735HA SJA14473736HA SJA14473737HA SJA14473744HA SJA14473745HA SJA14473746HA SJA14473764HA SJA14473766HA SJA14473767HA SJA14473769HA SJA14473770HA SJA14473771HA SJA14473772HA SJA14473773HA SJA14473776HA SJA14473777HA SJA14473778HA SJA14473780HA SJA15031792HA SJA15031794HA SJA15031799HA SJA15031800HA SJA15031801HA SJA15031802HA SJA15031803HA SJA15031804HA SJA15031805HA SJA15031806HA SJA15031807HA SJA15031808HA SJA15031809HA SJA15031810HA SJA15090147HA SJA15090150HA SJA15090174HA SJA15090176HA SJA15090677HA SJA15090678HA SJA15090679HA SJA15090680HA SJA15090681HA SJA15090682HA SJA15101017HA SJA15101019HA SJA15252140HA SJA15252155HA SJA15252156HA SJA15252160HA SJA15252161HA SJA15252162HA SJA15252163HA SJA15252167HA SJA15252168HA SJA15262002HA SJA15262092HA SJA15262093HA SJA15262094HA SJA15262155HA SJA15262156HA SJA15262157HA SJA15262158HA SJA15262160HA SJA15262161HA SJA15262163HA SJA15262165HA SJA15301023HA SJA15301024HA SJA15301025HA SJA15301026HA SJA15301027HA SJA15301028HA SJA15301029HA SJA15301030HA SJA15301031HA SJA15301032HA SJA15301033HA SJA15301035HA SJA15301037HA SJA15301038HA SJA15312155HA SJA15312167HA SJA15312168HA SJA15312169HA SJA15312170HA SJA15312171HA SJA15312172HA SJA15312173HA SJA15312175HA SJA15312176HA SJA15312177HA SJA15312178HA SJA15312179HA SJA15312180HA SJA15312181HA SJA15312184HA SJA15312185HA SJA15312186HA SNE15510283HA SNE15510293HA SJA14246442HA SJA14257632HA SJA14257641HA SJA14257642HA SJA14257643HA SJA14257644HA SJA14257645HA SJA14257646HA SJA14257647HA SJA14257648HA SJA14257649HA SJA14257650HA SJA14257663HA SJA14257664HA SJA14257665HA SJA14257666HA SJA14257667HA SJA14497353HA SJA14497354HA SJA14497355HA SJA14497356HA SJA14507577HA SJA14507578HA SJA15391004HA SJA15391007HA SJA15391012HA SJA15391013HA SJA15392085HA SJA15392086HA SJA15392087HA SNE160310

Distribution pattern

Worldwide Distribution-US Nationwide

device · product 2 of 2

GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: 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 is indicated for monitoring of: -hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation). -Respiratory (impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange) and -neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission. The CARESCAPE Monitor B850 also provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices.

Z-0096-2019
Recall number
Z-0096-2019
Initiated
September 04, 2018
Classification
Class II
Status
Ongoing
Recalling firm
GE Healthcare Finland Oy
Quantity
47,937 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.

Code information

Serial Numbers: No UDI: SKA14365373GA SKA16085338SA SKA16085415SA SED11178711GA SED11178722GA SED11178730GA SED11178731GA SED12384211GA SKA16065074SA SKA16065096SA SKA16105698SA SKA16105700SA SED11148380GR SED11168558GR SED11229587GR SED12183123GA SED12183126GA SED12273483GA SED12353647GA SED12353648GA SED12363714GA SED12363728GA SED12373928GA SED09320537GA SED11300215GR SED11300224GR SED11300285GR SED11300317GR SED11300318GR SED11420905GR SED11420906GR SED11420913GR SED11420919GR SED11420923GR SED11420926GR SED11420927GR SED11420928GR SED11420929GR SED11420930GR SED11420931GR SED11430946GR SED11430947GR SED11430949GR SED11430967GR SED11430970GR SED11430971GR SED12152834GR SED12152838GR SED12203208GR SED12203211GR SED12203212GR SED12203213GR SED12203254GR SED12203257GR SED12203258GR SED12203259GR SED12253445GR SED12263455GR SKA14365468GA SED11097478GR SED11158484GR SED11229574GR SED11229586GR SED11229600GR SED11290119GR SED11290121GR SED11290179GR SED11300185GR SED11300206GR 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Distribution pattern

Worldwide Distribution-US Nationwide