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U.S. Department of Health and Human Services

Class 2 Device Recall F2 Frame (F201)

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  Class 2 Device Recall F2 Frame (F201) see related information
Date Initiated by Firm September 08, 2023
Date Posted September 29, 2023
Recall Status1 Open3, Classified
Recall Number Z-2656-2023
Recall Event ID 93054
510(K)Number K223531  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
Code Information UDI/DI 010019527852408921, Serial Numbers: SUT23230108HA, SUT23230111HA, SUT23240034HA, SUT23240035HA, SUT23230106HA, SUT23230107HA, SUT23230109HA, SUT23230110HA, SUT23230112HA, SUT23230113HA, SUT23230114HA, SUT23240001HA, SUT23240002HA, SUT23240003HA, SUT23240004HA, SUT23240005HA, SUT23240006HA, SUT23240007HA, SUT23240008HA, SUT23240009HA, SUT23240010HA, SUT23240011HA, SUT23240012HA, SUT23240013HA, SUT23240014HA, SUT23240015HA, SUT23240016HA, SUT23240018HA, SUT23240019HA, SUT23240020HA, SUT23240021HA, SUT23240022HA, SUT23240023HA, SUT23240024HA, SUT23240025HA, SUT23240026HA, SUT23240027HA, SUT23240028HA, SUT23240029HA, SUT23240030HA, SUT23240032HA, SUT23230100HA, SUT23230101HA, SUT23230102HA, SUT23240017HA, SUT23240036HA, SUT23240037HA, SUT23240038HA, SUT23240039HA, SUT23240040HA, SUT23240042HA, SUT23240043HA, SUT23240044HA, SUT23240048HA, SUT23240049HA, SUT23240050HA, SUT23240051HA, SUT23240052HA, SUT23240053HA, SUT23240054HA, SUT23240055HA, SUT23240056HA, SUT23240057HA, SUT23240058HA, SUT23240059HA, SUT23240060HA, SUT23240061HA, SUT23240062HA, SUT23240063HA, SUT23240064HA, SUT23240065HA, SUT23240066HA, SUT23240067HA, SUT23240068HA, SUT23240069HA, SUT23240070HA, SUT23240071HA, SUT23240081HA, SUT23240082HA, SUT23240083HA, SUT23270053HA, SUT23270054HA, SUT23270057HA, SUT23270058HA, SUT23270059HA, SUT23270060HA, SUT23270061HA, SUT23270062HA, SUT23270063HA, SUT23270065HA, SUT23270066HA, SUT23270067HA, SUT23270068HA, SUT23270069HA, SUT23280003HA, SUT23280004HA, SUT23280005HA, SUT23280006HA, SUT23280007HA, SUT23280008HA, SUT23280009HA, SUT23280010HA, SUT23280011HA, SUT23280012HA, SUT23230085HA, SUT23230089HA, SUT23230090HA, SUT23230091HA, SUT23230092HA, SUT23230093HA, SUT23230094HA, SUT23230095HA, SUT23230096HA, SUT23230097HA, SUT23230098HA, SUT23230099HA, SUT23230103HA, SUT23230104HA, SUT23230105HA, SUT23250033HA, SUT23250035HA, SUT23250037HA, SUT23250039HA, SUT23250043HA, SUT23250044HA, SUT23250053HA, SUT23250054HA, SUT23250055HA, SUT23250056HA, SUT22300099HA, SUT22300100HA, SUT22300106HA, SUT22390047HA, SUT22390049HA, SUT22390051HA, SUT22390052HA, SUT22390053HA, SUT22430001HA, SUT22430003HA, SUT22470003HA, SUT23100028HA, SUT23100030HA, SUT23100031HA, SUT23100032HA, SUT23100033HA, SUT22500038HA, SUT22500039HA, SUT23100015HA, SUT23100016HA, SUT23100017HA, SUT22510033HA, SUT23240046HA, SUT23240047HA, SUT22290026HA, SUT22290081HA, SUT22300101HA, SUT22300104HA, SUT22390017HA, SUT22390019HA, SUT22390020HA, SUT22390021HA, SUT22390022HA, SUT22390024HA, SUT22390031HA, SUT22390032HA, SUT22390033HA, SUT22390034HA, SUT22390036HA, SUT22390038HA, SUT22390039HA, SUT22390041HA, SUT22390042HA, SUT22390043HA, SUT22390044HA, SUT22390045HA, SUT22390046HA, SUT22390048HA, SUT22390050HA, SUT22390055HA, SUT22390057HA, SUT22430002HA, SUT22430004HA, SUT22430005HA, SUT22430006HA, SUT22470001HA, SUT22470002HA, SUT22470004HA, SUT22470006HA, SUT22470007HA, SUT22470010HA, SUT22470012HA, SUT22470014HA, SUT22470015HA, SUT22470017HA, SUT22470018HA, SUT22470019HA, SUT22470020HA, SUT22470021HA, SUT22500014HA, SUT22500015HA, SUT22500017HA, SUT22500022HA, SUT22500025HA, SUT22500029HA, SUT22500034HA, SUT22500035HA, SUT22500037HA, SUT22500052HA, SUT22500054HA, SUT22500056HA, SUT22500058HA, SUT22500060HA, SUT22500061HA, SUT22500063HA, SUT22500073HA, SUT22500075HA, SUT23100007HA, SUT23100036HA, SUT23100037HA, SUT23100038HA, SUT23100039HA, SUT23100040HA, SUT23100041HA, SUT23100042HA, SUT23100043HA, SUT23100044HA, SUT23100045HA, SUT23110001HA, SUT23110002HA, SUT23110003HA, SUT23110004HA, SUT23110005HA, SUT23110006HA, SUT23110007HA, SUT23110008HA, SUT23110009HA, SUT23110010HA, SUT23110014HA, SUT23110020HA, SUT23110021HA, SUT23110022HA, SUT23110023HA, SUT23110024HA, SUT23110035HA, SUT23110066HA, SUT23110067HA, SUT23120023HA, SUT23120024HA, SUT23120025HA, SUT23120026HA, SUT23120027HA, SUT23120028HA, SUT23120029HA, SUT23120030HA, SUT23120031HA, SUT23120033HA, SUT23120034HA, SUT23120041HA, SUT23120042HA, SUT23120044HA, SUT23120046HA, SUT23120047HA, SUT23120048HA, SUT23130001HA, SUT23130002HA, SUT23130003HA, SUT23130004HA, SUT23130005HA, SUT23130006HA, SUT23130025HA, SUT23130026HA, SUT23130027HA, SUT23130028HA, SUT23130029HA, SUT23130030HA, SUT23130031HA, SUT23130032HA, SUT23130033HA, SUT23130034HA, SUT23130035HA, SUT23130036HA, SUT23130041HA, SUT23130042HA, SUT23130043HA, SUT23130044HA, SUT23130045HA, SUT23140001HA, SUT23140002HA, SUT23140003HA, SUT23140007HA, SUT23140008HA, SUT23140009HA, SUT23140010HA, SUT23140011HA, SUT23140012HA, SUT23140013HA, SUT23140014HA, SUT23140015HA, SUT23140022HA, SUT23140023HA, SUT23140024HA, SUT23140025HA, SUT23140026HA, SUT23140027HA, SUT23140043HA, SUT23140044HA, SUT23140045HA, SUT23150001HA, SUT23150002HA, SUT23150003HA, SUT23150004HA, SUT23150005HA, SUT23150006HA, SUT22300061HA, SUT22300064HA, SUT22300069HA, SUT22300078HA, SUT22300079HA, SUT22300083HA, SUT22300097HA, SUT22380009HA, SUT22380011HA, SUT22520034HA, SUT22520037HA, SUT23200244HA, SUT23200245HA, SUT23200246HA, SUT23200249HA, SUT23200250HA, SUT23200251HA, SUT23200252HA, SUT23200253HA, SUT23200254HA, SUT23200255HA, SUT23200256HA, SUT23200257HA, SUT23200258HA, SUT23200259HA, SUT23200265HA, SUT23230003HA, SUT22300019HA, SUT22300031HA, SUT22300091HA, SUT22470060HA, SUT22470061HA, SUT22470062HA, SUT22470063HA, SUT22470064HA, SUT22470065HA, SUT22470066HA, SUT22470067HA, SUT22470068HA, SUT22470069HA, SUT22470070HA, SUT22470075HA, SUT22480001HA, SUT22480002HA, SUT22480004HA, SUT22480006HA, SUT22480008HA, SUT22480010HA, SUT22480012HA, SUT22480013HA, SUT22480015HA, SUT22480018HA, SUT22480020HA, SUT22480021HA, SUT22480022HA, SUT22480025HA, SUT22480026HA, SUT22480028HA, SUT22480032HA, SUT23050026HA, SUT23050046HA, SUT23050049HA, SUT23050051HA, SUT23060002HA, SUT23060004HA, SUT23060009HA, SUT23060010HA, SUT23060011HA, SUT23060012HA, SUT23060013HA, SUT23060014HA, SUT23060015HA, SUT23060016HA, SUT23060017HA, SUT23060018HA, SUT23060019HA, SUT23060020HA, SUT23060021HA, SUT23060022HA, SUT23060023HA, SUT23060024HA, SUT23060025HA, SUT23060026HA, SUT23060027HA, SUT23060028HA, SUT23060029HA, SUT23060030HA, SUT23060031HA, SUT23060032HA, SUT23060033HA, SUT23060034HA, SUT23060035HA, SUT23060036HA, SUT23060037HA, SUT23060038HA, SUT23060039HA, SUT23060040HA, SUT23060041HA, SUT23070001HA, SUT23070002HA, SUT23070003HA, SUT23070004HA, SUT23070005HA, SUT23070006HA, SUT23070007HA, SUT23070008HA, SUT23070009HA, SUT23070010HA, SUT23070011HA, SUT23070012HA, SUT23070013HA, SUT23070014HA, SUT23070015HA, SUT23070016HA, SUT23070017HA, SUT23070018HA, SUT23070019HA, SUT23070020HA, SUT23070021HA, SUT23070022HA, SUT23070023HA, SUT23070024HA, SUT23070025HA, SUT23070026HA, SUT23070027HA, SUT23070028HA, SUT23070029HA, SUT23070030HA, SUT23070031HA, SUT23070032HA, SUT23070033HA, SUT23070034HA, SUT23070035HA, SUT23070036HA, SUT23070037HA, SUT23070038HA, SUT23070039HA, SUT23070040HA, SUT23070041HA, SUT22380003HA, SUT22380005HA, SUT22380006HA, SUT22380007HA, SUT22380008HA, SUT22380010HA, SUT22380013HA, SUT22380015HA, SUT22380026HA, SUT22380032HA, SUT22380034HA, SUT22380036HA, SUT22380037HA, SUT23170138HA, SUT23180162HA, SUT22510120HA, SUT22280018HA, SUT22300037HA, SUT22300041HA, SUT22300042HA, SUT22300043HA, SUT22300044HA, SUT22300045HA, SUT22300046HA, SUT22300047HA, SUT22300048HA, SUT22300051HA, SUT22300052HA, SUT22300053HA, SUT22300054HA, SUT22300055HA, SUT22380014HA, SUT22380018HA, SUT22380020HA, SUT22380021HA, SUT22380022HA, SUT22380025HA, SUT22380030HA, SUT22380031HA, SUT22380033HA, SUT22380035HA, SUT22380038HA, SUT22380039HA, SUT22380040HA, SUT22380046HA, SUT22380048HA, SUT22380049HA, SUT22380051HA, SUT22380053HA, SUT22380055HA, SUT23090042HA, SUT22300025HA, SUT22300026HA, SUT22300028HA, SUT22300029HA, SUT22300030HA, SUT22300033HA, SUT22300034HA, SUT22300035HA, SUT22300036HA, SUT22300038HA, SUT22510107HA, SUT22520005HA, SUT22520026HA, SUT22520027HA, SUT22520028HA, SUT22520029HA, SUT22520030HA, SUT22520033HA, SUT22520036HA, SUT22520042HA, SUT22520044HA, SUT22520045HA, SUT22520046HA, SUT22520047HA, SUT22520048HA, SUT23300004HA, SUT23300005HA, SUT23300006HA, SUT23300007HA, SUT23300024HA, SUT23300025HA, SUT23300041HA, SUT23180208HA, SUT23110034HA, SUT23110036HA, SUT23160042HA, SUT22520031HA, SUT22520035HA, SUT22520038HA, SUT23300002HA, SUT23300008HA, SUT23300010HA, SUT23300026HA, SUT22300065HA, SUT22300068HA, SUT22300070HA, SUT22300073HA, SUT22300074HA, SUT22300075HA, SUT22300077HA, SUT22300080HA, SUT22300081HA, SUT22300082HA, SUT22300084HA, SUT22300098HA, SUT22300102HA, SUT22300105HA, SUT22300111HA, SUT22310050HA, SUT22310051HA, SUT22310052HA, SUT22310053HA, SUT22310054HA, SUT22310055HA, SUT22310058HA, SUT22310059HA, SUT22310060HA, SUT22310061HA, SUT22310062HA, SUT22310063HA, SUT22310064HA, SUT22310065HA, SUT22310066HA, SUT22310067HA, SUT22310068HA, SUT22310069HA, SUT22310070HA, SUT22310071HA, SUT22310072HA, SUT22310073HA, SUT22310074HA, SUT22310075HA, SUT22310076HA, SUT22310077HA, SUT22310078HA, SUT22310079HA, SUT22310080HA, SUT22310081HA, SUT22310082HA, SUT22310083HA, SUT22310084HA, SUT22310085HA, SUT22310086HA, SUT22310087HA, SUT22310088HA, SUT22310089HA, SUT22310090HA, SUT22310091HA, SUT22310092HA, SUT22310099HA, SUT22310100HA, SUT22310102HA, SUT22310103HA, SUT23230086HA, SUT23230087HA, SUT23080005HA, SUT23080006HA, SUT23080007HA, SUT23080008HA, SUT23080009HA, SUT23080010HA, SUT23080018HA, SUT23070063HA, SUT23070066HA, SUT23080001HA, SUT23080002HA, SUT23080003HA, SUT23080011HA, SUT23080013HA, SUT23080014HA, SUT23080015HA, SUT23080016HA, SUT23080017HA, SUT22510013HA, SUT22510014HA, SUT22510015HA, SUT22510016HA, SUT22510019HA, SUT22510021HA, SUT22510024HA, SUT22510025HA, SUT22510026HA, SUT22510027HA, SUT22510028HA, SUT22510030HA, SUT22510031HA, SUT22510032HA, SUT22510036HA, SUT22510037HA, SUT22510038HA, SUT22510039HA, SUT22510040HA, SUT22510041HA, SUT22510042HA, SUT22510044HA, SUT22510045HA, SUT22510046HA, SUT22510047HA, SUT22510048HA, SUT22510049HA, SUT22510050HA, SUT22510051HA, SUT22510052HA, SUT22510053HA, SUT22510054HA, SUT22510055HA, SUT22510057HA, SUT22510060HA, SUT23050002HA, SUT23050004HA, SUT23050008HA, SUT23050010HA, SUT23050012HA, SUT23050014HA, SUT23050016HA, SUT23050021HA, SUT23050027HA, SUT23050028HA, SUT23050029HA, SUT23050030HA, SUT23050032HA, SUT23050033HA, SUT23050034HA, SUT23050035HA, SUT23050036HA, SUT23300046HA, SUT23300048HA, SUT23300051HA, SUT23120045HA, SUT23130014HA, SUT23150047HA, SUT23160002HA, SUT23160022HA, SUT23160028HA, SUT23160060HA, SUT23160061HA, SUT23160062HA, SUT23160067HA, SUT23160070HA, SUT23160071HA, SUT23160073HA, SUT23170075HA, SUT23170077HA, SUT23170078HA, SUT23170079HA, SUT23170080HA, SUT23170081HA, SUT23170082HA, SUT23170083HA, SUT23170084HA, SUT23170085HA, SUT23170087HA, SUT23170088HA, SUT23170089HA, SUT23170090HA, SUT23170092HA, SUT23170093HA, SUT23170094HA, SUT23170095HA, SUT23170096HA, SUT23170097HA, SUT23170098HA, SUT23170099HA, SUT23170100HA, SUT22380041HA, SUT22380042HA, SUT22380043HA, SUT22380044HA, SUT22380045HA, SUT22380047HA, SUT22380050HA, SUT22380052HA, SUT22380054HA, SUT22380056HA, SUT22380057HA, SUT22380058HA, SUT22380059HA, SUT22380060HA, SUT22380061HA, SUT22380062HA, SUT22380063HA, SUT22380064HA, SUT22380065HA, SUT22380066HA, SUT22380067HA, SUT22380068HA, SUT22380069HA, SUT22380070HA, SUT22380071HA, SUT22380072HA, SUT22380073HA, SUT22380074HA, SUT22380075HA, SUT22380076HA, SUT22380077HA, SUT22380078HA, SUT22380079HA, SUT22380080HA, SUT22380081HA, SUT22380082HA, SUT22380083HA, SUT22380084HA, SUT22380085HA, SUT22380086HA, SUT22380087HA, SUT22380088HA, SUT22380089HA, SUT22390001HA, SUT22390002HA, SUT22390003HA, SUT22390004HA, SUT22390005HA, SUT22390006HA, SUT22390007HA, SUT22390009HA, SUT22390010HA, SUT22390011HA, SUT22390012HA, SUT22390013HA, SUT22390014HA, SUT22390015HA, SUT22390016HA, SUT22390018HA, SUT22390025HA, SUT22390026HA, SUT22390027HA, SUT22390028HA, SUT22390029HA, SUT22390030HA, SUT22390035HA, SUT22390037HA, SUT22390040HA, SUT22390054HA, SUT23120020HA, SUT23170074HA, SUT23170076HA, SUT23170086HA, SUT23170091HA, SUT23170103HA, SUT23180217HA, SUT23180221HA, SUT23180223HA, SUT23180224HA, SUT23050037HA, SUT23050038HA, SUT23050039HA, SUT23050040HA, SUT23050041HA, SUT23050045HA, SUT23050047HA, SUT23050048HA, SUT23050050HA, SUT23060001HA, SUT23060003HA, SUT23060005HA, SUT23060006HA, SUT23060007HA, SUT23060008HA, SUT22500065HA, SUT22500067HA, SUT22500069HA, SUT22500079HA, SUT22500081HA, SUT22500083HA, SUT22500085HA, SUT22500087HA, SUT22480059HA, SUT22480040HA, SUT22480042HA, SUT22480044HA, SUT22480045HA, SUT22480046HA, SUT22480050HA, SUT22480051HA, SUT22480052HA, SUT22480053HA, SUT22480054HA, SUT22480055HA, SUT22480056HA, SUT22480058HA, SUT22480060HA, SUT22480063HA, SUT22480066HA, SUT22480067HA, SUT22480069HA, SUT22480071HA, SUT22480073HA, SUT22480075HA, SUT22480077HA, SUT22480078HA, SUT22480079HA, SUT23180163HA, SUT23180164HA, SUT23180168HA, SUT23180170HA, SUT23180172HA, SUT23180175HA, SUT23180177HA, SUT23180183HA, SUT23180185HA, SUT23180186HA, SUT23180187HA, SUT23180188HA, SUT23180189HA, SUT23180194HA, SUT23180195HA, SUT23180197HA, SUT23180198HA, SUT23180199HA, SUT23180200HA, SUT23180202HA, SUT22480033HA, SUT22480037HA, SUT22480038HA, SUT22310016HA, SUT22310026HA, SUT22310027HA, SUT22310028HA, SUT22310029HA, SUT22310030HA, SUT22310032HA, SUT22310035HA, SUT22310036HA, SUT22310039HA, SUT22310040HA, SUT22310041HA, SUT22310043HA, SUT22310044HA, SUT22310047HA, SUT22310048HA, SUT22310049HA, SUT22310124HA, SUT22310125HA, SUT22310127HA, SUT22310128HA, SUT22380002HA, SUT22380023HA, SUT22500009HA, SUT22470048HA, SUT22470050HA, SUT22470051HA, SUT22470052HA, SUT22470053HA, SUT22470054HA, SUT22470055HA, SUT22470057HA, SUT22470058HA, SUT22470059HA, SUT22470071HA, SUT22500064HA, SUT22500066HA, SUT22500068HA, SUT22500070HA, SUT22500072HA, SUT22500074HA, SUT22500076HA, SUT22500077HA, SUT22500078HA, SUT22500080HA, SUT22500082HA, SUT22500084HA, SUT22500086HA, SUT22500088HA, SUT22500089HA, SUT22500090HA, SUT22500091HA, SUT22500092HA, SUT22500093HA, SUT22500094HA, SUT22500095HA, SUT22500096HA, SUT22500097HA, SUT22500098HA, SUT22500099HA, SUT22500100HA, SUT22500101HA, SUT22500102HA, SUT22500104HA, SUT22500105HA, SUT22500106HA, SUT22500107HA, SUT22500108HA, SUT22500109HA, SUT22500110HA, SUT22500111HA, SUT22500112HA, SUT22500113HA, SUT22500114HA, SUT22500115HA, SUT22500116HA, SUT22500117HA, SUT22500118HA, SUT22500119HA, SUT22500121HA, SUT22500122HA, SUT22500123HA, SUT22500124HA, SUT22500125HA, SUT22500126HA, SUT22500127HA, SUT22500128HA, SUT22500129HA, SUT22500130HA, SUT22500131HA, SUT22500132HA, SUT22500133HA, SUT22500134HA, SUT22500135HA, SUT22510001HA, SUT22510002HA, SUT22510003HA, SUT22510004HA, SUT22510005HA, SUT22510006HA, SUT22510007HA, SUT22510008HA, SUT22510009HA, SUT22510010HA, SUT22510011HA, SUT22510012HA, SUT22520039HA, SUT22520040HA, SUT22520041HA, SUT23100012HA, SUT23170101HA, SUT23170102HA, SUT23170104HA, SUT23170105HA, SUT23170106HA, SUT23170107HA, SUT23170108HA, SUT23170109HA, SUT23170110HA, SUT23170111HA, SUT23170112HA, SUT23170113HA, SUT23170117HA, SUT23170118HA, SUT23170119HA, SUT23170120HA, SUT23170121HA, SUT23170122HA, SUT23170124HA, SUT23170128HA, SUT23170130HA, SUT23170133HA, SUT23170134HA, SUT23170135HA, SUT23170141HA, SUT23170142HA, SUT23170143HA, SUT23170144HA, SUT23180147HA, SUT23180148HA, SUT22280025HA, SUT22510029HA, SUT22510106HA, SUT22510109HA, SUT22510110HA, SUT22510111HA, SUT22510112HA, SUT22510116HA, SUT22510118HA, SUT22520001HA, SUT22520004HA, SUT22520006HA, SUT22520007HA, SUT22520008HA, SUT22520010HA, SUT22520011HA, SUT22520012HA, SUT22520015HA, SUT22520016HA, SUT23300013HA, SUT23300033HA, SUT23300038HA, SUT23050001HA, SUT23050007HA, SUT23050009HA, SUT23050011HA, SUT23050013HA, SUT23050015HA, SUT23050017HA, SUT23050020HA, SUT23050022HA, SUT23050023HA, SUT23050024HA, SUT23050025HA, SUT23050043HA, SUT23300045HA, SUT23300047HA, SUT23300049HA, SUT22310001HA, SUT22310003HA, SUT22310004HA, SUT22310005HA, SUT22310006HA, SUT22310010HA, SUT22310012HA, 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Recalling Firm/
Manufacturer		 GE Medical Systems China Co., Ltd.
National Hi-Tech
No. 19 Changjiang Road; Dev. Zone
Wuxi China
For Additional Information Contact GE HealthCare Service
800-437-1171
Manufacturer Reason
for Recall		 There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors if the F2-01 Frame has not been powered down within the last 120 days.
FDA Determined
Cause 2		 Software design
Action The consignee recall notification was sent out via FedEx on 09/08/2023. The letter instructs the consignee that they can continue to use the F2-01 Frame by completing the power down instructions located within the letter at least every 90 days, until GE HealthCare has corrected the affected device. The consignee is also requested to ensure all potential users in your facility are made aware of this safety notification and the recommended actions; retain the document for their records; and to complete and return the attached acknowledgement form to Recall.36160@ge.com.
Quantity in Commerce 1638 units
Distribution Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Cyprus, Czech Republic, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, New Zealand, Oman, Poland, Qatar, Saudi Arabia, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = GE Healthcare Finland Oy
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