Recall archive / FDA device enforcement
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms) — FDA record Z-2656-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 8, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- GE Medical Systems China Co., Ltd.
- Quantity
- 1638 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2656-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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,... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Oct 11, 2023
- Recall initiation date
- Sep 8, 2023
- Center classification date
- Sep 29, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.