CLASS II ONGOING Device recall · Reported 11 Oct 2023 · FDA Enforcement Report
F2-01 Frame, physiological patient monitor recalled
GE Medical Systems China is recalling F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms), distributed nationwide in the US. The recall was initiated on 8 Sep 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2656-2023
- FDA event ID
- 93054
- Recalling firm
- GE Medical Systems China, Wuxi, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Sep 2023
- FDA classified
- 29 Sep 2023
- Reported
- 11 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 8 Sep 2023 | Recall initiated by company | |
| 29 Sep 2023 | Classified by FDA | +21 days |
| 11 Oct 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
Where it was distributed
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.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from GE Medical Systems China
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MAC 5 A4 Resting ECG Analysis System recalled | GE Medical Systems China | Device Malfunction | Nationwide |
| Device | CLASS I | GE Healthcare Carestation anesthesia system Power recalled | GE Medical Systems China | Device Malfunction | Nationwide |
| Device | CLASS I | GE Healthcare Carestation anesthesia system, product number recalled | GE Medical Systems China | Device Malfunction | Nationwide |
| Device | CLASS I | GE Healthcare Carestation anesthesia system, product number recalled | GE Medical Systems China | Device Malfunction | Nationwide |
| Device | CLASS II | GE Healthcare Logiq F R3 Ultrasound System recalled | GE Medical Systems China | Other |
Other Patient Monitors recalls
All 1,013| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |