GE Medical Systems, LLC: Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

Recall number

Z-2468-2024

Recalling firm

GE Medical Systems, LLC

Product

Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

Status

Open, Classified

Initiated

2024-06-14

Posted

2024-08-02

Terminated

not on file

Reason

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Root cause

Device Design

Action

GE Healthcare issue an URGENT MEDICAL DEVICE CORRECTION to its consignees via letter on 06/14/2024. The letter explained the problem with the device, safety issue, and requested the following: "Actions to be taken by Customer/User: You can continue to use your MR system by following the instructions below: To ensure that the displayed B1+RMS value on the Scan Prescription User Interface does not exceed the user prescribed limit specified in the Low SAR Mode User Interface: " If your software version includes the Optimized T2 FLAIR Sequence option, enable this option by setting the value to 1.00. This option is present on the Advanced Tab of the Scan Prescription User Interface. " If your software version does not include the Optimized T2 FLAIR Sequence option, adjust scan parameters such as TR , # Slices or Auto Refocus Flip Angle until the displayed B1+RMS value on the Scan Prescription User Interface does not exceed the user prescribed limit. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

Quantity

1607 units

Distribution

Worldwide distribution.

Lot, serial or model codes

System ID: 907562450W, 907IAPMR1, 256ASURGMR1, 334826450W, 205991MR2, 205LMK450W, 205877450W, 205939450W, 205783450W, 205838MR4, 256840MR450W, 251621450W, 256973MR450, 334287MR, 251279MR1, 256571MR450W, 256737H450W, 205949MR450W, 256GMTMR450W, 256880MR1, 256HHMR2, 256881MR1, 256ODCMR1, 256HICMR2, 205702450W, 251435MR15T, 251450MR, 251476MR, 205333MR1, 334732HDMR, 334676450W, 251SARAMR, 334418450W, 256386MR450, 334636MR, STVT450W, 205750MR6, 205750MR5, 205450WSMR, 479754MR, 501585450W, 479571MR, 479709450W, 479452450W, 501346MR1, 501225450W3, 501225450W2, 501225450W1, 501221LEGACY450, 501202MR1, 870541JR450W1, 479964450W, 479757NW450, 870208MR450, 928214MR1, 480425MR9, 928453MW450W, 520666MR1, 480425MR11, 702616RDLMR, 480425MR8, 480882MR1, 623524MR1, 520TMCMR1, 520STMMR, 520ACPMR2, 520SMICMR, 6628, RADNETMR667, RADNETMR593, 916961450MR, 77266MR02, 619409MR1, RADNETMR630, 7462, 760452MR1, 6970K, 949557MR1, 530IIMR, 7951, 7688, 858824MR2, 661949MR450, 562826MR1, 562491MR2, ALLIANCEOPT02, 310289MR, ASLW450W, RADNETMR610, 209491SSMR, 951486MR, QUEEN450WMR, 818NHMR1, 510449MR450W, 530ORO450W, 6947, 8061, 951788MR, 916783450MR, 916SUTROSMR, UCDACCMR450, 916MCCMR, 415754QMR1, 8590, 619295HDMR2, 858549HDMR1, 415KSF450W, 415KMB450W, 408259MR450W, 510784MR450W, 510784MR450WSIL, 805898MR, 707576MR450W, 707521MR450W, 707546MR450W, 209SJMR, RADNETMR634, AVHTVGEMR, 805SCMR, 760830MR, 707651KVMR, 805CHMR1, 925210450WMR, 707459MR450W, 7493, 970544MR450W, 303341MR, 303444MR, 303498MR1, 303446MR, 719285DVMR, 303866MR, 719260MR, 970874MR, 303861MR1, 303427MRW, DOA450W, 720484MR, 970858MR, 303278MR, 303338MR2, 303338MR1, 303416MR, 720SAHMOBMR, 720708MR, 303673MR, 303269MR, 303577DVMR, 719560MR3, 970625MR450W, 970870450W, 303451MR, 303426MR, 303467MR, 203837MR450W, 860749MR, 860678450W, 203863MR450W, 203325MR450W, 860489MR450W, 203574MR450W, INSIGHTMR3244, 202476MR2, 302993MR, 561642MR3, 561642MR3RAD, 239VAMR2, 239VA450MR, 727462MR1, 954688MR1, 954346MR1, 863422MR1, 561495MR2, 904215MR11, 772LMCMR1, RADNETMR1692, 850862MR1, 305696MR450W, 352344MR3, 904308MR1, 904202MR10, 904202MR8, 904202MR7, 904223MR1, 561747MR2, 407OSCMR2, 407PMCMR, 386LCMR, 321WMC450W, 305835MR450W, 305854MR1, 850SHHDMR, NNHMR450W, 904639MR1, 407359MR, 850475450W, 850431450W, 813866MR, 813926MR1, 813972MR4, 813745MR5, 813745MR2, 00506MRS01, 561795MR2, 561845MR2, 863295MR, MSF072-1-26668WE8, 3011062, 706922MR, 770848MR, 770219BUMR, 3008010, 706494450W, 770918GEMR2, 770918GEMR, 912384MR1, 478272MR1, 706635450W, 706787450DV, 770533WMR, 706845MR, 478743450W, 770252MR, 912576MR, 3000158, 229228450W, 808HRAWMR, 808TAMCMR450W, 712243MR450, 515263MR450, 641754MR1, 712722MR, 319272MR, 319768MR, 515358MR1, 208678MR, WVMR450W, 208882MR450W, 847658OI450W, 630859MR1, 630264MRI, 847381MR, 630755AMR, 815705MR, 312563CMR, 773962SBMR, 773525MR3, 217876MR2, 847298MR, 217876FMR, 1000004458, 630208DMR2, 630384MRI, 618253MR, 217532DVMR, 847SAMCMR3, 815937MR, 1000004456, 847438MR, 217732LMR, 630946MR1, 630873MR, 1000004278, 217258SBMR1, 708681GMR, 630527MR4, 630527MR3, 815215MR, 815300MR1, 630724ROMR, 708684MR1, 630684MR450W, 708346MR5, 708346MR6, 708660ROPMR, 708361DVMR, 773792MRI, 309691P450W, 1000004986, 309691MR, 1000004469, 309672MR450W, 1000004048, 815399MR4, 1000004298, 815399MR2, 815971MR2, 815664MR450W, 815758MR, 815217MR1, 708429MRI, 630352MRI, 630716AMR, 847872ZMR1, 765646MR450, 260920MR, 812276HDXT, 812897MR1, 574546MR, 765365MR, 765362MR1, 574266MR, 260426VAMR, 765448MR450, 574335GMR, 765655MR, 317388MR, 317204MR1, 317338MR5, 317887MR2, 317865MR3, 765502MR1, 812265MR, 574335MR, 812858MWMR, 812842MR1, 812858OAMR, 812352HDXT, 260563450W, 574267450W, 574267MR, 765502MR2, 620442MR, 785239MR, 620275MR, 785623MR2, 620285MR450, 913682LVMRW, 913397DICOMRW, 913676SMBVMR, 913469JCMR, 913676SUNMR, 785452SMR2, 785TPVAMRW, 316268MR450, 316262MR450, 316858MR450, 620221WMR, 270527MMR, 859301MR, 502868MR3, 859442MR, 270251JPMR, 270441LMR, 270444LMR1, 859744MR450, 318769MR, 225ICL450W, 985ONCMR, 985NOMR3, 985873TMR4, 337593MR2, 504VAMR15, 985SAMR, 318798450W, 985447MR15, 985WCMR15, 337363MR450, ALLIANCEOPT01, MSF061-1-1Z7GPHJZ, MSF061-1-20JU-1055, MSF061-1-20JU-1056, MSF061-1-20JU-1057, MSF061-1-20JU-1058, MSF061-1-20JU-1059, MSF061-1-20JU-1264, MSF061-1-20JU-1265, MSF061-1-20JU-1266, MSF061-1-20JU-1268, MSF061-1-20JU-1476, MSF061-1-20JU-1477, MSF061-1-20JU-1479, MSF061-1-20JU-1480, MSF061-1-20JU-1690, MSF061-1-20JU-1692, MSF061-1-20JU-1693, MSF061-1-20JU-1694, MSF061-1-20JU-1901, MSF061-1-20JU-1902, MSF061-1-20JU-1903, MSF061-1-20JU-1904, MSF061-1-20JU-1905, MSF061-1-20JU-197, MSF061-1-20JU-200, MSF061-1-20JU-201, MSF061-1-20JU-2111, MSF061-1-20JU-2112, MSF061-1-20JU-2114, MSF061-1-20JU-2115, MSF061-1-20JU-2331, MSF061-1-20JU-2332, MSF061-1-20JU-3195, MSF061-1-20JU-3196, MSF061-1-20JU-3407, MSF061-1-20JU-3408, MSF061-1-20JU-3409, MSF061-1-20JU-3410, MSF061-1-20JU-3411, MSF061-1-20JU-415, MSF061-1-20JU-416, MSF061-1-20JU-417, MSF061-1-20JU-418, MSF061-1-20JU-419, MSF061-1-20JU-632, MSF061-1-20JU-633, MSF061-1-20JU-634, MSF061-1-20JU-635, MSF061-1-20JU-843, MSF061-1-20JU-844, MSF061-1-20JU-845, MSF061-1-20JU-846, MSF061-1-2336-80024, MSF061-1-2701Y0FK, MSF061-1-27MG1GBU, MSF061-1-2B6T-12893, MSF061-1-2B6T-173074, MSF061-1-2B6T-59585, MSF061-1-2B8TE81Q, MSF061-1-2JNX8OTC, MSF061-1-2KIQGX1X, MSF061-1-2L2WDE0S, MSF061-1-2M80VFWX, MSF061-1-2RT9JOE9, MSF061-1-2VA2GB6P, MSF061-1-2WU53JR5, 617499MR2, 978287MR, 508548MR, STLUKESOPTMR, ALLIANCEOPT05, MORTON450WMR, 413568MR, 781HV450MR, 410266MR3, RADNETMR1691, 240480MR, RADNETMR1614, 301295MR8, 301295MR6, 301295MR5, RADNETMR1588, 240566MR2, RADNETMR1721, RADNETMR1604, 240313MR, 301279MR3, RADNETMR1660, RADNETMR1594, 207973MR450W, 207338MR450W, 207OA450WMR, 313593MR450, 1000000576, 616774MR450W, 616391450W, 616267MR450, 517668MR, 517450W, ALLIANCEOPT06, 248898MR450, 989907MR, 586573MR450, 507373MR1, 952831MR3, 218828MR, 952456MR450, 320523MR1, 651267MR1, MR229053, MR229045, MR229043, MR229044, MR229042, MR229040, 651287MR1, 651968MR450W, WH231MR450, 816932BSMRW, 417348MR2, 417358MR2, 573815MR4, 636933JMR1, 573556MRW2, 417STJ4502, 417STJ450, 816861MR1, 816932MRW, 816561MRW, 314543SAMR1, 417533MR3, 816347GEMR, 417354MR1, 573686VA450W, 314251MMR2, 417269MCMR3, 417COXMR2, 636239DVMR, 636MOTIONMR, 601932MR450W, 601968MR450W1, 601354MR450W, 662932MRIROC, 662841MR5, 406293MR450W, 406543ART2, 336625DVMR, 828225MRW, 828213RMRW, BRUNSWICKMR, 828883MR450, 704323DVMR, 704384MR450, 828456MRW, 704403DVMR, 919470GEM1, 252482MR450, 910609MR2, 910609CFMR1, 910323VRIMR, 530225MR, 252847MR450W, 252436MPMR, 828696MRW, 910577GEM, 828759MR1, 910CHMR450W, 704CMCLMCMR, 704660DVMR, 910CFHOKEMR, 336503PMMR, 919JM450W, 910457MR, 828586MRW, HERITAGEMR, 910642MR, 910667MR, 910WHMR, 910NHO450W, 336765MR1, 336760DVMR, 701567MR450, SMSLMS4, 308398HDMR, 308995PMR, 402SEMR450W, 402873NEBMR, 402609ONMR, 308255MR, 609407MR, 201858MRW, 908277MR1, PENNCH450W, RADNETMR6069, 732450WMR, 973301MR2, 973301MR, 609242MR450W, 441MR450, 609584MR450W, 973322MRW, 973325MR, 201579MRW, 609267MR, 732776MR450W, 732938MR, 732249MR, 973926MR, 609380MR, HSSPRMSMR450W, 908859MR, 732892MR450W, RADNETMR1650, 973361MR, 732246WMR, 908685MR450W, 201836MRW, 732557MR450W, 908851MR, 856794MR, 856768MR, RADNETMR6061, 908232MR450W, 505262MR, 505863MR450, 505287MR, 575622MRW1, 702616MR450W, 702PKWYMR, 775SMMR450W, 518842MRI, 914273MRW, SINAIQ2MR450W, SINAIQMR450W, 631968MR, MKMG450W, 718270MR, RADNETMR1722, 518579MR, 631499MR450, 631623MR450, 631689MR450, 315MDRBRIT, ALLIANCEOPT03, 631723MR450, 845794MRW, 718738MR, 631923MR, INSIGHTMR3249, 845943MR, 315823MR, 631405MR450, ORMCMR1, RADNETMR1603, 212523MR3SS, MSPACC450W, RSVLTMR1450W, 212255MR, MSK53MR01, MSK68MR04, MR9ALLEN450W, RADNETMR1655, RADNETMR1674, HSSMAGNETI, HSSMAGNETH, 315922MR, 315SOSNORTH, 716712MR, 518563MRI, 518561MR, 845483MR, 516705MR450, 518897MR, 718818MR, 631638MR450, 845368MRW, 315SOS450W, 516HSSMR, WMED450W, RADNETMR649, 914288MRI, WMED450W2, 513732MR, 740439450W, 513584RIDMR, 513782MR, 513584MR2, 513624MR2, 513MWMR1, 614RMHTMR1, 440890450W, 419PRODEF, 614LCHCMR, 937278MR2, 513870MR1, 937WHMR, 614663MR, 614HMOBMR, 614MCHFMR, 440960MR450W, 419ARROWMR, 419STCHARLESMR, 419PERRYMR, 740886MRW, 419455MR, 419251MR, 419WYMR, 513298MR2, 513298MR3, 513298MR1, 440827MR450W, 330263450W, 740454MR, 918333JPMR2, 918333JPMR1, 580251MR2, 405359EMR, 918787MR, 405912MMR, 405307NMR2, 405486MR2, 405842ACMR, 405271PMR1, 405271PMR2, 405814MR, 405270VMR2, 405486MR, 580765PMR, 918523MR2, 918879MR, 918712MR1, 918744SJMR3, 918744SJMR1, 918893TCIMR, 918744SJMR2, 918599MR, 918307MR, 918523MR450, 541706MR, 541317MR, 541SAGHMR, 503216PRC, 971310MR1, 541947MR, 503723PWFMR1, 541276MR450W, 503732MR1, 503220MR1, 610674MR, 610740MR4, 717867MR, 724773MR450W, PENNMEDMR, 412851MR, 610317MR, 610954MRW, 610997MRW, 610831450W, 814260MR450W, 724772MR, JOI610450W, 484503MR, 724981MR450W, 814643MR450W, 215949MR, 717272MR, 717485MR1, 412942MR2, 814333MR450W, 717791MR1, 717975MR2, 412372MR1, 215JEANESMR, 215707450W, 215537MR, METHODISTMR450W, PHILLYNAVYMR, 215ARIA450W, JHN450W, 215829MR1, STCHRISMR, 412647PUHMR2, 412232MR450W, 724934MR, 412358MR2, 412623SDHYMR3, 814676MR450W, 814234MR450W, 484526MR, 215201MR, 724229MR1, MRH1154, 864225DVMR, 843762CCMR, 803791MRI, 803434DVMR, 803751MR, 843292MR450, 864255SFMR, 864675ESMR, 864725MRI, 843784450W, 843339450W, 803313DVMR, 803329DVMR, 864560DVMR, 605725MR, 605217MR450W, 605721MR450, 605322MR2, 605322MR, 605677MR450W, 423844MR1, 423553MR450, 931245MR2, 901GTMR450XP, 901755MR450, 901GTMR450, 424622OPT1, 731661MR1, 731541MROP2, 865471MR450, 865545450W, 865525MR2, 615TO2, 901REGIONONE450, 901VAMR450W, 901384MR450, 901726MR450, 615329VAN, 615327MR450, 615PRADMR1, 731644MR2, 931363MR450W, 931967MR450W, 325307HPMR, 325670HMR1, 325670ICMR, 817472TSMR1, 512UTMR, 512TSIMR1, 512816SAMR, 979CTSMMR1, 512CPMCMR2, 214828MPMR1, 972566WMR2, 972566WMR4, 214341PDDMR2, 214302PDWMR1, 817BSFWMR1, 817FPMCMR1, 817321RATCMR1, 972495TSGMR1, 512GTMRI, 956365MRW, 713792AMR20, 713792AMR15, 303466MR, RADNETMR685, 713798MR2, 713441MR6W, 713792AMR13, VINTAGE450, 972868TLCMR1, 972969LCMR, 817482BKMR1, 832995MR1, 281348450WMR, 210WHASCMR2, 512LRMCMR, 806775MR, 806775MR450, 903927MR450, 469820BMWMR1, 254562MR450W, 432221MR, 936569MR450W, 830500RHMR1, 817255NHMR, 432333MR, 903731MR450, 903737PRWMR1, 713PRLDMR1, 432447MR1, 956487MRW, 210617HUBMR2, 210MSMTMR, 210MSSPMR, 903870BSHWMR1, SPRINGWOODMR1, 281276MR450W, 903439HC450W, 281943MR450, 903877UT450W, 972923BWAXMR, 281338MR450, 469649EWMR1, 435868MR, 435716MR1, 801IMCMR02, 801IMCMR4, 801262MR3, 801387MR1, 801479MR2, 801373MR5, REVERESGMR2, 801321LMR1, 801535MR1, 801501MR2, 801475MR1, 801GR450WGEM, 703664MR, 540953MR450, 434MJMR1, 757312MR, 804CHI450W, 434799MR1, 571349MR1, 276236MR450, 540862MR, 276666MR450W, 804WAT450, 757886MR1, 757261MR, 757398MR450W, 757953450WMR, 703205MR2, 276596450W, 804CHIP450W, 804OV450W, 804330MR450W, 434447MR, 802371MR, 206244HM450, 425450PMR, 425222SMRW, 360507450WCM, 509546MR450W, 425111SMRW, 509946NWOMR, 509TCOMR450W, 206292SR450W, 509482450W, 509837MR450W, 253596GHTMR, 360571MR1, 509573MR450W, 715623MRW, 920885MR2, 262303MR1, 262785MR1, 608930MR1, 414325WB1, 262656MR1, 608775MR1, 608890MR450W, 608263MR4I, 715748MR1, 262243MR1, 414649WB3, 414805MR1, 262687MR1, 304367MR450W, INSIGHTMR3248, 307ELEVMR, 307587MR, 307SWRMR, DZ1006MR01, DZ1101MR01, DZ1714MR01, DZ1525MR01, MR3698AR, MR6815AR, MRHM0774, MRHMO893, MRHM1139, MRHM1148, MRHM0560, MR9459AR, MRHM1192, MRHM0930, MRHM0559, MRHM1405, MRHM1496, MRHM1176, AM1019MR01, 83109684989, 0910272085, 83174615975, 83155846259, 83115138353, 83096537610, 83120699996, 83096322871, 83121616194, 83107577438, BH1037MR01, BY4027MR02, BY4190MR01, BY4084MR01, BY4184MR01, BY4033MR02, BY4178MR01, BY4160MR02, BY4035MR01, BY4033MR01, 210036MR02, MRHM1424, MRHM1361, MRHM1346, MRHM1315, MRHM1244, MRHM1141, MRHM1310, MRHM0842, MRHM1536, MRHM0158, MRHM1460, MRHM1260, MRHM1268, MRHM0711, MRHM0649, MRHM0430, MRHM0145, MRHM1100, MRHM0712, MRHM1065, MRHM1406, MRHM1213, MRHM0788, MRHM1297, MRHM1278, MRHM0177, MRHM0208, MRHM1207, MR307144MR6, MRHM1317, MRHM1217, MRHM0350A, MRHM1837, MRHM0950, MRHM0342, MRHM0885, MRHM0448, MRHM0264, MRHM1033, MRHM1719, MRHM1601, MRHM1704, MRHM1577, MRHM1596, MRHM1572, MRHM1590, MRHM1566, MRHM1551, MRHM1544, MRHM1309, MRHM1119, MRHM1061, MRHM0937, MRHM0897, MRUA0184, MRHM0323, MRHM0523, MRHM0409, MRHM0358, MRHM0269, MRHM0267, MRHM0266, MRHM0228, 2879385, 2884624, BG4013MR01, BG4693MR01, 403777MR2, 403670MR1, 613938MR1, 450466MR1, 514934MR1, 514934MR2, 514890GEMR1, 514890GEMR2, E416249MR1, 604582MR450, 416212MR450, 902893MR1, 506544MR1, 506739MR1, 506862MR2, 905522MR2, 613721MR1, 416486MR4, 514262MR1, 450654MR450, 306569MR1, MR8485CL, MR4187CL, MRHM1067, HR4199MR01, CS1343MR01, CS1236MR01, DK1001MR02, DK1047MR05, DK1044MR02, DK1044MR03, DK1029MR04, DK1042MR02, DK1645MR01, MRHM1288, MRHM1323, EG1097MR03, EG1024MR02, EG1958MR01, EE4012MR01, FI1149MR01, FI1023MR02, FI1015MR05, FI1015MR04, M4166668, M4042028, M1754007, E4167655, GF1006MR01, M4172346, M4464821, MQ1000MR01, M4176535, M4486930, M5173635, M4516029, T4185506, M2795512, X41944006, X41944020, NC1028MR01, PF1000MR02, X616331701, M5400573, M40180132, M4040554, M41980122, G4197601, M4145035, X681864011, GF1001MR01, X4211004, M6015637, GE1158MR01, GE1216MR01, HAMB01MR01, PC4318MR02, UC1590MR04, 662455MR01, HC4218MR04, PC0303MR02, CC3398MR02, 387194MR01, 210219MR01, 805534MR01, HC9039MR01, 527556MR01, PKOB02MR06, HC2555MR01, 418262MR01, CC5340MR01, 118150MR01, HC6474MR01, 604529MR01, HC2259MR02, 220068MR01, CC6785MR01, 446281MR01, 355495MR02, PC0352MR02, HWIL01MR01, 125528MR03, CC7903MR01, 898660MR01, H10645MR23, H7009MR07, H43381MR02, MR6821GT, 0828270043IB01, 0828270037IB01, HU1906MR01, HU1113MR01, SYNMR001, HU1047MR01, 083027600046413, 083027606283420, 083027003811911, 083027822002316, 083027860027512, 083027605463214, 083027601000614, 083027605456914, 083027608914014, 0835270042, 5512MR0005, 0835270039, IR2273MR01, IR2047MR01, IR2243MR01, IR2088MR01, IR1814MR01, IR1925MR01, IR1519MR01, IR1310MR02, IQ1397MR01, IQ1638MR01, IQ1127MR01, IQ1578MR01, IE1079MR02, IE1053MR02, IE1226MR02, IL1059MR01, IL1041MR10, IL1194MR02, D174150001, D5343401, A5366629, A5383313, A5312220, A356832101, A5808532, A6012608, A5119449, A5813110, A126322010, A343134113, A5303339, A209695501, A232197306, A5228517, E5803915, F5367812, A6233904, A5381507, A56364172, A5274842, A457982901, B5105197, A5145927, A5272210, A5358122, A5295818, A5167933, A5196821, A5379317, A5214949, A51529155, B5354501, A202090803, A5359213, A409329103, A5634729, A5164526, A5354109, A5249511, E5141702, EM0152, EM0153, EM0117, EM0127, EM0106, EM0111, EM0124, EM0105, EM0150, EM0170, EM0113, EM0138, EM0135, EM0177, EM0119, EM0108, EM0110, EM0128, EM0121, EM0103, EM0122, EM0132, EM0125, EM0130, EM0141, EM0120, EM0101, EM0142, EM0123, EM0114, EM0151, EM0112, EM0129, EM0139, EM0133, EM0134, EM0155, EM0145, EM0137, EM0200, EM0136, EM0118, EM0109, EM0140, EM0116, EM0107, EM0115, EM0131, EM0104, EM0126, JO1053MR01, KA2856MR01, 0850270654, 0850270329, 0850270337, KW1102MR02, KW1100MR01, KW1067MR02, KW1067MR01, KW1011MR01, KW1011MR02, KW1005MR06, KW1005MR07, KW1005MR08, KW1098MR01, LB1331MR02, LB1027MR01, LB1250MR01, LB1348MR01, LY1086MR02, LT4003MR02, LT4089MR03, LT4041MR02, 1553MR0006, MRHM1736A, MRHM1986, MRHM2173, MR45W1800001, MRHM2181, MRHM1958, MRHM0967, MRHM0722, MR307145MR3, MRHM0562, MRHM1306, MRHM1053, MRHM2187, MRHM0828, MA1521MR02, MA1521MR01, MA1135MR02, RTD0424, RTD0422, TLB0229, UDN0120, 0920279032, NO1146MR02, OM1000MR02, OM1010MR01, PK1539MR01, PK1462MR01, PK1415MR01, PK1032MR01, PK1297MR01, PK1031MR01, PK1479MR01, MR8753PA, MRHM1427, MRHM1366, 1557MR0004, PL0739MR01, PL1735MR03, PL1735MR02, PL2902MR01, PL1499MR03, P00642MR01, PL2822MR02, PL1196MR01, PL1609MR04, P00007MR01, P00678MR01, PL1029MR01, PL3478MR01, P00495MR01, PL1426MR03, PL1059MR02, PL1501MR03, PL1502MR01, PL1190MR01, PL1491MR03, PL1684MR02, PL2773MR01, PL3362MR02, PL2762MR01, PL1544MR02, PPR07934, PPR83716, PPR00613, MRHM1126, MRHM1154, QA1125MR01, RO1104MR02, RO1426MR01, RO1096MR03, RO1188MR01, RF1737MR01, RF0444MR01, RF2839MR01, RU0004MR02, RU3293MR02, RU3637MR01, RU2076MR02, RU2551MR01, RU3007MR01, RU1158MR01, RU6340MR01, RU0472MR01, RU7346MR02, RU7346MR01, RU3362MR01, RU2580MR02, RU3894MR01, RU2527MR01, RU1127MR03, 600098MR01, RU2272MR02, RU2442MR01, RU1089MR07, RU1089MR06, RU1106MR02, RU9000MR01, RU7285MR01, RU1086MR05, RU1516MR01, RU8541MR01, RU1092MR02, RU1089MR05, RU8438MR02, RU7620MR01, RU9515MR01, RU7762MR01, RF0209MR01, RU3970MR01, RU0063MR01, RU1050MR02, RU9940MR01, RU2526MR02, RU1143MR02, RU3464MR01, RF1204MR01, RU0740MR01, RU3431MR01, RF0309MR01, RU1153MR01, RU2804MR01, SA1014MR03, SA2135MR02, SA1060MR01, SA2591MR01, SA1051MR02, SA1080MR01, SA1037MR02, SA1188MR04, SA1188MR03, SA2385MR01, SA1035MR01, SA2315MR01, SA1004MR03, SA1036MR03, SA1253MR01, SA1052MR03, SA2339MR01, SA2079MR01, SA1272MR01, SA1208MR01, SA1306MR01, SA1255MR02, SA2460MR01, SA2513MR01, SA2454MR01, SA5000MR01, SA5000MR02, SA5003MR01, SA1031MR02, SA1034MR03, SA1001MR04, SA1054MR03, SA1054MR04, SA1026MR01, SA1058MR04, SA1011MR04, SA2000MR01, SA1257MR01, SA1279MR03, SA1279MR01, SA1175MR01, SA1332MR01, RS4014MR01, RS4199MR01, 0847270027, 6073MR0015, 6073MR0010, 6073MR0007, 0847270031, SI4120MR02, SI4120MR01, ZA2195MR01, ZA3164MR01, DPN85203, NP739728, MP720808, UPW07915, DPN89112, DPM88007, DPN36504, MEX68909, DPN88623, NEV13613, FPD10804, DPD26400, FPD30600, F009MR01, E001MR03, Z001MR03, A042MR03, A203MR04, A203MR05, A020MR04, A106MR01, A101MR01, S003MR01, 350010MR04, 899010MR03, 959204MR01, 124826MR01, 122002MR01, 541010MR05, 0853270162, 0853270208, 0853270171, 0853270128, 0853270172, 0853270120IB1, 0853270178, 0853270154, 0853270144, 0853270140, 0853270127, 0853270165, 0853270153, 0853270147, 0853270135, 0853270175, 0853270148, 0853270130, 0853270169, 0853270160, 0853270196, 0853270183, 0853270137, 0853270185, 0853270173, 0856270072, 0856270062, 0856270063, 1573MR0013, TN1624MR01, TN1678MR01, TN1674MR01, 19002MRS03, 06049MRS01, 34405MRS01, 34388MRS01, 34389MRS01, 34386MRS01, 34387MRS01, 34368MRS01, 34006MRS04, 34524MRS01, 06002MRS04, UA4369MR01, UK1142MR01, AE1212MR01, AE1007MR02, AE1742MR01, AE1558MR01, AE1477MR01, AE1036MR01, AE1015MR01, AE1027MR01, AE1042MR01, AE1235MR01, AE1122MR01, AE1200MR01, AE1476MR01, 00538MRS01, 10580MRS01, IE1566MR01, 05169MRS02, 00373MRS01, 05228MRS01, IE1564MR02, IE1267MR01, 10683MRS01, 70001MRS13, 70001MRS10, 00440MRS04, 10671MRS01, 00246MRS01, 01507MRS01, 01110MRS01, 00393MRS02, 10443MRS01, 00556MRS02, 00556MRS03, 00680MRS01, 00132MSS02, 01215MRS01, 77526MRS01, 10307MRS04, 01305MRS01, 10462MRS02, 00213MRS02, 00568MRS03, 00259MRS01, 21274MRS01, 00669MRS02, 01314MRS01, 20483MRS01, 00768MRS01, 00223MRS03, 10537MRS01, 11073MRS02, 00084MRS02, 10429MRS01, 10036MRS01, 7911, 864282MRW, 2948529MR, UZ1049MR01, UZ1041MR01, UZ1010MR01, UZ1043MR01, UZ1031MR01, UZ1021MR01, MRHM1085, MRHM0454, ESMRI26851837.

510(k) numbers

["K132376","K160618","K163331","K142085"]

PMA numbers

not on file

Product code

LNH

Firm FEI

2183553

Firm city

Waukesha

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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