F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
FDA Device Recall #Z-2656-2023 — Class II — September 8, 2023
Recall Summary
| Recall Number | Z-2656-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 8, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Medical Systems China Co., Ltd. |
| Location | Wuxi, N/A |
| Product Type | Devices |
| Quantity | 1638 units |
Product Description
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
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.
Distribution Pattern
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.
Lot / 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, SUT22310033HA, SUT22310034HA, SUT22310046HA, SUT22310126HA, SUT22370013HA, SUT22370014HA, SUT22380017HA, SUT22380019HA, SUT23240041HA, SUT22500023HA, SUT22480093HA, SUT22480095HA, SUT22500001HA, SUT22500003HA, SUT22500012HA, SUT22500013HA, SUT22500016HA, SUT22500021HA, SUT23200241HA, SUT23200260HA, SUT23120043HA, SUT23130007HA, SUT23130008HA, SUT23130009HA, SUT23130010HA, SUT23130011HA, SUT23130012HA, SUT22310057HA, SUT22480057HA, SUT22480086HA, SUT22480088HA, SUT22480090HA, SUT22480092HA, SUT23110058HA, SUT23110059HA, SUT23140004HA, SUT23140005HA, SUT23140006HA, SUT23180157HA, SUT23180169HA, SUT23180174HA, SUT23180191HA, SUT23180201HA, SUT23180204HA, SUT23180206HA, SUT23180215HA, SUT23180216HA, SUT23180220HA, SUT23180222HA, SUT23180225HA, SUT23180226HA, SUT23110040HA, SUT23110041HA, SUT23110048HA, SUT23110060HA, SUT23110061HA, SUT23110068HA, SUT23110069HA, SUT23110070HA, SUT23110071HA, SUT23110072HA, SUT23120004HA, SUT23120005HA, SUT23120006HA, SUT23120007HA, SUT23120008HA, SUT23120009HA, SUT23120016HA, SUT23120017HA, SUT23120035HA, SUT23120036HA, SUT23120037HA, SUT23120038HA, SUT23120039HA, SUT23120040HA, SUT23120049HA, SUT23120050HA, SUT23120051HA, SUT23120052HA, SUT23120053HA, SUT23120054HA, SUT23130013HA, SUT23130015HA, SUT23130016HA, SUT23130017HA, SUT23130018HA, SUT23130020HA, SUT22300027HA, SUT22300057HA, SUT22300058HA, SUT22300060HA, SUT22300063HA, SUT22300066HA, SUT22300071HA, SUT22300076HA, SUT22310042HA, SUT22500026HA, SUT22510020HA, SUT22510022HA, SUT22510023HA, SUT22390023HA, SUT23050018HA, SUT23050042HA, SUT23090023HA, SUT23090024HA, SUT23090025HA, SUT23090026HA, SUT23090003HA, SUT23090004HA, SUT23090005HA, SUT23090006HA, SUT23090007HA, SUT23090008HA, SUT23090009HA, SUT23090010HA, SUT23090011HA, SUT23090012HA, SUT23090013HA, SUT23090014HA, SUT23090021HA, SUT23090022HA, SUT23090035HA, SUT23090036HA, SUT23090038HA, SUT23090040HA, SUT23090053HA, SUT23100002HA, SUT23100004HA, SUT23100005HA, SUT23100006HA, SUT23110037HA, SUT23110038HA, SUT23110039HA, SUT23110042HA, SUT23110050HA, SUT23110051HA, SUT23110052HA, SUT23110053HA, SUT23110054HA, SUT23110062HA, SUT23110063HA, SUT23110064HA, SUT23110065HA, SUT23110073HA, SUT23110074HA, SUT23110075HA, SUT23120001HA, SUT23120002HA, SUT23120003HA, SUT22500018HA, SUT22500019HA, SUT23200232HA, SUT23110011HA, SUT23110012HA, SUT23110013HA, SUT23110017HA, SUT23110018HA, SUT23110019HA, SUT23110025HA, SUT23110026HA, SUT23110027HA, SUT23110028HA, SUT23110029HA, SUT23110030HA, SUT23110031HA, SUT23110032HA, SUT23110033HA, SUT23110043HA, SUT23110044HA, SUT23110045HA, SUT23110046HA, SUT23110047HA, SUT23110049HA, SUT23110055HA, SUT23110056HA, SUT22300059HA, SUT22300062HA, SUT22300103HA, SUT22300107HA, SUT22300108HA, SUT22300109HA, SUT22300110HA, SUT22300112HA, SUT22510058HA, SUT22510062HA, SUT22510079HA, SUT22510104HA, SUT23090037HA, SUT23090043HA, SUT23090044HA, SUT23090047HA, SUT23090048HA, SUT23090050HA, SUT23090051HA, SUT23090052HA, SUT23090055HA, SUT23090056HA, SUT23090057HA, SUT23090058HA, SUT23090059HA, SUT23100001HA, SUT23100003HA, SUT23090027HA, SUT23090028HA, SUT23090029HA, SUT23090030HA, SUT23090031HA, SUT23090032HA, SUT23090041HA, SUT23090045HA, SUT23090046HA, SUT23090049HA, SUT23120010HA, SUT23120011HA, SUT23120012HA, SUT23120013HA, SUT23120014HA, SUT23120015HA, SUT23120022HA, SUT23120032HA, SUT23090015HA, SUT23090016HA, SUT23090017HA, SUT23090018HA, SUT23090019HA, SUT23090020HA, SUT23090039HA, SUT23120018HA, SUT23120019HA, SUT23120021HA, SUT23180214HA, SUT22470056HA, SUT22500103HA, SUT22500120HA, SUT22510056HA, SUT22510059HA, SUT22510061HA, SUT22510063HA, SUT22510064HA, SUT22510065HA, SUT22510066HA, SUT22510067HA, SUT22510068HA, SUT22510069HA, SUT22510070HA, SUT22510072HA, SUT22510073HA, SUT22510074HA, SUT22510075HA, SUT22510076HA, SUT22510077HA, SUT22510078HA, SUT22510080HA, SUT22510081HA, SUT22510082HA, SUT22510083HA, SUT22510084HA, SUT22510085HA, SUT22510086HA, SUT22510087HA, SUT22510088HA, SUT22510089HA, SUT22510091HA, SUT22510092HA, SUT22510093HA, SUT22510094HA, SUT22510095HA, SUT22510096HA, SUT22510097HA, SUT22510098HA, SUT22510099HA, SUT22510100HA, SUT22510101HA, SUT22510102HA, SUT22510103HA, SUT22510105HA, SUT23160037HA, SUT23160039HA, SUT23160040HA, SUT23160053HA, SUT23160054HA, SUT23160055HA, SUT23160056HA, SUT23160057HA, SUT23160058HA, SUT23160064HA, SUT23300015HA, SUT23300022HA, SUT23300029HA, SUT23300032HA, SUT23300034HA, SUT23300035HA, SUT23300039HA, SUT23300040HA, SUT22300067HA, SUT23080004HA, SUT23080024HA, SUT23080025HA, SUT23080026HA, SUT23080027HA, SUT23080028HA, SUT23080029HA, SUT23080033HA, SUT23080037HA, SUT23080038HA, SUT23080039HA, SUT23080040HA, SUT23080041HA, SUT23080046HA, SUT23080047HA, SUT23080048HA, SUT23080049HA, SUT23080050HA, SUT23080051HA, SUT23080052HA, SUT23080053HA, SUT23080054HA, SUT23080055HA, SUT23090001HA, SUT23090002HA, SUT22480081HA, SUT22510017HA, SUT22510018HA, SUT22510034HA, SUT22510035HA, SUT22280009HA, SUT22280011HA, SUT22280041HA, SUT22280042HA, SUT23180210HA, SUT23180211HA, SUT22500040HA, SUT22500041HA, SUT22500042HA, SUT22500046HA, SUT22500048HA, SUT22500049HA, SUT22500050HA, SUT22500051HA, SUT22480085HA, SUT23100018HA, SUT23100019HA, SUT23100020HA, SUT23100021HA, SUT23100022HA, SUT23100023HA, SUT22470005HA, SUT22470072HA, SUT22470073HA, SUT22470074HA, SUT22480003HA, SUT22480005HA, SUT22480007HA, SUT22480016HA, SUT22480017HA, SUT22480019HA, SUT22290006HA, SUT22290007HA, SUT22290015HA, SUT22290025HA, SUT22290042HA, SUT22290045HA, SUT22290062HA, SUT22290064HA, SUT22300003HA, SUT22300004HA, SUT22300006HA, SUT22300007HA, SUT22300008HA, SUT22300013HA, SUT22300014HA, SUT22300015HA, SUT22300016HA, SUT22300020HA, SUT22300021HA, SUT22300022HA, SUT22300024HA, SUT22300039HA, SUT22300049HA, SUT22300050HA, SUT22300089HA, SUT22300090HA, SUT22300092HA, SUT22300093HA, SUT22300094HA, SUT22300095HA, SUT22300096HA, SUT22310122HA, SUT22310123HA, SUT23070042HA, SUT23070043HA, SUT23070044HA, SUT23070045HA, SUT23070046HA, SUT23070047HA, SUT23070048HA, SUT23070049HA, SUT23070050HA, SUT23070051HA, SUT23070052HA, SUT23070053HA, SUT23070054HA, SUT23070055HA, SUT23070056HA, SUT23070057HA, SUT23070058HA, SUT23070059HA, SUT23070060HA, SUT23070061HA, SUT23070062HA, SUT23070065HA, SUT22480068HA, SUT22480070HA, SUT22480089HA, SUT22480091HA, SUT23100013HA, SUT23180150HA, SUT23180151HA, SUT23180153HA, SUT23180173HA, SUT23180176HA, SUT23070064HA, SUT23080019HA, SUT23080020HA, SUT23080021HA, SUT23080022HA, SUT23080023HA, SUT22480009HA, SUT22480011HA, SUT22480014HA, SUT22480023HA, SUT22480024HA, SUT22480027HA, SUT22480029HA, SUT22480030HA, SUT22480031HA, SUT22480034HA, SUT22480035HA, SUT23160063HA, SUT23160066HA, SUT23080030HA, SUT23080031HA, SUT23080032HA, SUT22500044HA, SUT22500045HA, SUT22500047HA, SUT22500071HA, SUT22500043HA, SUT23180165HA, SUT23180166HA, SUT23180167HA, SUT23180171HA, SUT23180180HA, SUT23180181HA, SUT23180182HA, SUT23180184HA, SUT22290023HA, SUT22290079HA, SUT22290080HA, SUT22290082HA, SUT22310011HA, SUT22310017HA, SUT22310023HA, SUT22310024HA, SUT22470008HA, SUT22470009HA, SUT22470011HA, SUT22470013HA, SUT22470016HA, SUT22470022HA, SUT22470023HA, SUT22470024HA, SUT22470026HA, SUT22470028HA, SUT22470029HA, SUT22470032HA, SUT22470035HA, SUT22470036HA, SUT22470037HA, SUT22470038HA, SUT22470039HA, SUT22470040HA, SUT22470041HA, SUT22470044HA, SUT22470045HA, SUT22470047HA, SUT22480036HA, SUT22480039HA, SUT23180155HA, SUT23180158HA, SUT23180160HA, SUT22310013HA, SUT22310014HA, SUT22310015HA, SUT22310018HA, SUT22310019HA, SUT22310020HA, SUT22310022HA, SUT22310056HA, SUT22470027HA, SUT22470030HA, SUT22470031HA, SUT22470033HA, SUT22470034HA, SUT22470042HA, SUT22470043HA, SUT22470046HA, SUT22470049HA, SUT23080012HA, SUT23080034HA, SUT23080035HA, SUT23080036HA, SUT23080042HA, SUT23080043HA, SUT23080044HA, SUT23080045HA, SUT22310002HA, SUT22310007HA, SUT22310008HA, SUT22310009HA, SUT22310021HA, SUT22310025HA, SUT22310031HA, SUT22310037HA, SUT22310038HA, SUT22310093HA, SUT22310094HA, SUT22310095HA, SUT22310096HA, SUT22310097HA, SUT22310098HA, SUT22310101HA, SUT22310104HA, SUT22310105HA, SUT22310106HA, SUT22310107HA, SUT22310108HA, SUT22310109HA, SUT22310110HA, SUT22310111HA, SUT22310112HA, SUT22310113HA, SUT22310114HA, SUT22310129HA, SUT22310130HA, SUT22310131HA, SUT22310132HA, SUT22310133HA, SUT22370001HA, SUT22370002HA, SUT22370003HA, SUT22370004HA, SUT22370005HA, SUT22370006HA, SUT22370007HA, SUT22370008HA, SUT22370009HA, SUT22370010HA, SUT22370012HA, SUT22370015HA, SUT22380001HA, SUT22380004HA, SUT22380016HA, SUT22380024HA, SUT22380027HA, SUT22380028HA, SUT22380029HA, SUT22310045HA, SUT22470025HA, SUT23100008HA, SUT23100009HA, SUT23100010HA, SUT23100011HA, SUT22480047HA, SUT22480048HA, SUT22480049HA, SUT22480062HA, SUT22480064HA, SUT22480065HA, SUT22500020HA, SUT22500031HA, SUT22500059HA, SUT22500062HA, SUT22500053HA, SUT22500055HA, SUT22500057HA
Other Recalls from GE Medical Systems China Co., Ltd.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0913-2026 | Class I | GE Healthcare Carestation anesthesia system, pr... | Nov 14, 2025 |
| Z-0915-2026 | Class I | GE Healthcare Carestation anesthesia system Pow... | Nov 14, 2025 |
| Z-0914-2026 | Class I | GE Healthcare Carestation anesthesia system, pr... | Nov 14, 2025 |
| Z-2029-2025 | Class II | GE Healthcare LOGIQ F R3 Ultrasound System, Mod... | May 16, 2025 |
| Z-2030-2025 | Class II | GE Healthcare Versana Ultrasound Systems, sold ... | May 16, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.