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F2-01 Frame, physiological patient monitor (with arrhythmia… recallZ-2656-2023 · GE Medical Systems China Co., Ltd. · initiated Sep 8, 2023

Class II Open, Classified All recalls posted in September 2023

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Medical Systems China Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Software design

What the company is doing

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 [email protected].

Recall details

Recall number
Z-2656-2023
Recall class
Class II
Status
Open, Classified
Initiated by the company
Sep 8, 2023
Posted by the FDA
Sep 29, 2023
Recalling firm
GE Medical Systems China Co., Ltd.
Quantity
1638 units
Product code
MHX
FDA submissions
K223531
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.

Product description

F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)

Code information (models, lots, serial numbers)

Show the full code information (25k characters)

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 devices under the same FDA submission

2 devices cleared under K223531 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page