GE Healthcare Discovery MR450…

Date

May 7, 2014

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare, LLC

Product

GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products. Affected devices are whole body magnetic resonance scanners indicated for use as a diagnostic imaging devices.

Reason

GE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products. Patient egress from the system can be delayed or impeded if the cradle release handle and/or cradle release block mechanism malfunctions or becomes misaligned. This could make the safe removal of the patient from the system difficult.

Distribution pattern

Worldwide Distribution -- USA, except ND, RI and WY, and including DC, Guam, and Puerto Rico; and, the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA,AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CAYMAN ISLANDS, CHINA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KOREA, KUWAIT, LEBANON, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, T UREY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, and VENEZUELA.

Quantity

1,548 units (704 US, 844 OUS).

Codes and lots

Mfg Lot or Serial # SystemID 00001250FMM026 919684DMPMR1 00000301309MR1 6628 00000000HM0426 6947 00000305379MR0 7462 00001018XF503B 205592750 00001227FMM00T 201445750W 00000297006MR9 202476MR1 00000296307MR2 202476MR2 00000297727MR0 202476MR3 00000300562MR6 202476MR4 00000000UA0153 202966MR3TW 00000305414MR5 203739MR450W 00000301842MR1 203863MR450W 00001203FMMOUJ 205750MR5 00000298836MR8 205838MR4 00000298249MR4 205949MR450W 00000301841MR3 206292SR450W 00000000UA0026 206292SR750W 00000293338MR0 206CH750MR 00000295024MR4 207945MR750 00001250FMM033 207OA450WMR 00000305461MR6 208882MR450W 00000299644MR5 209225VC450 00001026XF5173 209225VC750 00001105XF502C 209SJMR 00000000UA0143 210617HUBMR 00000300706MR9 210MSMTMR 00000000UA0052 21277MR1 00000301045MR1 212989MR1 00000305990MR4 212GE450W 00000301820MR7 214266PCBCMR1 00000302494MR0 214302PDWMR1 00000300930MR5 214590MWMRE3 00001250FMM02W 214645UT3TMR1 00000030251MR2 215ARIA450W 00000304079MR7 217223BHMR 00000303322MR2 217258SBMR1 00000294098MR9 217383CMR5 00000291464MR6 217528MR1 00000000HM0640 217532DVMR 00000299560MR3 217732LMR 00000292843MR0 217788MR3 00001250FMM02E 217876DMH3T 00000307113MR1 217876FMR 00000303450MR1 218828MR 00000000UA0203 225763MR2 00000306130MR6 229228450W 00000123FMM0K4 239VA450MR 00000296369MR2 240215MR 00000302363MR7 240313MR 00000301471MR9 240683MR 00000292634MR3 2486613TMR 00000298535MR6 252436MPMR 00000299171MR9 252482MR450 00001250FMM02T 252NDMR450W 00000296070MR6 253596GHTMR 00001307FMM05K 256881MR1 00001301FMM04T 256HHMR2 00000296840MR2 256HICMR2 00000302944MR4 256ODCMR1 00000303639MR9 260426VAMR 00000301255MR6 260920MR 00000302633MR3 262656MR1 00000301867MR8 262687MR1 00000308096MR7 262785mr1 00000295802MR3 269DVMR 00000000UA0138 270798MR2 00000294057MR5 281274MR1 00000000UA0028 281274MR2 00000290050MR4 281276MR750 00000298727MR9 281348450WMR 00000296429MR4 281364MR2 00001001BD6325 281477MR2 00000304177MR9 301295MR3T2 00000295215MR8 301295MR4 00001106XF5046 301295MR5 00000301518MR7 301295MR6 00000000UA0027 3014643TMR 00000300687MR1 301496MR3T4 00001301FMM047 301570MR 00000000HM0570 301618MR2 00001234FMM0J4 302993MR 00000298675MR0 303278MR 00000000HM0583 303338MR1 00000000HM0591 303338MR2 00000303940MR1 303426MR 00000304578MR8 303427MRW 00000303646MR4 303444MR 00000000UA0029 303604MR2 00000299213MR9 303699MR2 00000294494MR0 304256MR2 00000302631MR7 304766MR4 00000302248MR0 305243MR1 00001245FMM03P 305284MR1 00000000UA0085 305461MR1 00000304493MR0 305854MR1 00000301046MR9 308398HDMR 00001301FMM04G 309344MR450W 00000296469MR0 309662JMR450W 00000305101MR8 309672MR450W 00000296046MR6 309683MNMR750 00000305519MR1 310289MR 00000303805MR6 312355DVMR 00000301924MR7 312996MR3T 00000299952MR2 313593MR450 00000000UA0091 314577CGMR3T 00000301262MR2 315SOS450W 00000305521MR7 315SOSNORTH 00000303342MR0 316685MR 00001250FMM036 317338MR5 00000298399MR7 317865MR3 00000301519MR5 317887MR2 00000301190MR5 318769MR 00000299522MR3 319268MR 00000304355MR1 321FCMR1 00001301FMM045 330263450W 00000000UA0116 330344MR750W 00000300847MR1 330363450W 00000305176MR0 330489MR450W 00000000UA0144 337289MR1 00000000UA0074 337943MR1 00000029854MR5 352867MR 00000300987MR5 360507450WCM 00000298512MR5 360582450WPA 00000000UA0056 386FHPCMR3T 00000296908MR7 386FMR3T 00000302570MR7 402228MR 00000301013MR9 404329MR 00000000UA0034 405271OUCMR 00000299491MR1 405359EMR 00000302712MR5 405486MR 00000293561MR7 405752I3T 00000304151MR4 405912MMR 00001219FMM0GV 406375HMR 00000299141MR2 406543MR450W 00000305668MR6 407PMCMR 00000000UA0068 407SMSLMR1 00000000UA0083 408356MR1 00000302916MR2 412372MR1 00000299967MR0 412623MR1 00000300564MR2 412623SDHYMR3 00000298677MR6 412647PUHMR1 00000300494MR2 412647PUHMR2 00000298960MR6 412835MR1 00000306066MR2 412942MR2 00001307FMM01X 413568MR 00000000UA0167 414647MR1 00000298889MR7 414649WB3 00000298552MR1 414805MR1 00000298591MR9 414805MR2 00000300122MR9 414805MR4 00000297624MR9 415493VMR2 00000290202MR1 415723CHMR2 00000305165MR3 415723CHMR3 00000000HM0584 415723CHMR4 00000301295MR2 415723SCHMR2 00000291489MR3 415723SHMR10 00000000UA0057 415723SHMR12 00000000UA0064 415723SHMRW 00000000UA0073 415CB3TW 00000291877MR9 415L3TMR1 00000290773MR1 415L3TMR2 00000293261MR4 415OI3TMR 00000297877MR3 417COXMR1 00000302634MR1 417STJ450 00000303356MR0 417STJ4502 00000300704MR4 419407MR1 00000304799MR0 419893MR 00001307FMM019 419ARROWMR 00001301FMM03M 419PERRYMR 00001308FMM04V 419PRODEF 00000298932MR5 419WYMR 00000300906MR5 423553MR450 00000305617MR3 423844MR1 00000298908MR5 425111SMRW 00000299520MR7 425222SMRW 00000299823MR5 425450PMR 00000300713MR5 425688MR 00000299908MR4 425750PMR 00000300588MR1 434799MR1 00000301044MR4 434MJMR1 00000293646MR6 434UVAMR 00000000UA0089 435251MR1 00000297833MR6 435716MR1 00000302571MR5 441MR450 00000303375MR0 469820BMWMR1 00000305524MR1 479452450W 00000298861MR6 479757NW450 00000000HM0679 479964450W 00000298981MR2 480425MR6 00000294665MR5 480768MR2 00000301522MR9 484503MR 00000300473MR6 501202MR1 00000305102MR6 501221LEGACY450 00000304262MR9 501225450W1 00000306028MR2 501225450W2 00000302998MR0 501661VA450 00001250FMM021 502624MR2 00000303994MR8 503220MR1 00001213FMM0LF 504842MR2 00000299851MR6 505609MR 00000300967MR7 508548MR 00000300565MR9 508693MVMR 00000304851MR9 509332MR450W 00000299321MR0 509473DMR3T 00001236FMM01X 509482450W 00000298870MR7 509546MR450W 00000000HM0629 509837MR450W 00000000HM0461 509TCOMR450W 00000307611MR4 510449MR450W 00000301926MR2 510537MR750 00000306095MR1 512816SAMR 00000302545MR9 512LRMCMR 00000305982MR1 513732MR 00000306029MR0 513CCHGTMR 00001236FMM021 513MWMR1 00001106XF509C 515263MR450 00000296171MR2 515358MR1 00000296888MR1 515643MR450 00000000HM0529 516HSSMR 00000291397MR8 517353DVMR 00000298083MR7 517450W 00000030154MR0 517HILLMR 000005148810-3 518561MR 00000296841MRO 518563MRI 00000304440MR1 518579MR 00000306027MR4 520ACPMR2 00000301380MR2 520SMICMR 00000300764MR8 530876MR450 00000294556MR6 540665MR3T 00000299966MR2 540MIF3T750 00001250FMM020 541276MR450W 00000305667MR8 541317MR 00000292431MR4 541CMRIMR 00000297134MR9 541SAGHMR 0000000UA0001A 559734VIMR1 00000304494MR8 561747MR2 00000300900MR8 561795MR2 0000000UA0090A 561844MR1 00000298580MR2 570271MR6 00000296626MR5 573556MR450 00000305820MR3 573556MRW2 00000304763MR6 573756MAMR 00000296096MR1 573884MRI 00000301028MR7 574267MR 00000303812MR2 574335MR 00000305426MR9 574546MR 00000301401MR6 575622MRW1 00000305520MR9 580548BWB 00000000UA0071 585275MR750W 00000304508MR5 585785MR750 00000304720MR6 601354MR450W 00000300038MR7 601450W 00000304017MR7 601932MR450W 00000296462MR5 602588MR2 00000294576MR4 602830MR3 00001201FMM08B 602839MR1 00000000UA0096 6033343TW 00000295228MR1 6036503T 00000304719MR8 605322MR 00000303050MR9 605725MR 00000302688MR7 607CORNELL3T 00000299266MR7 608263MR4I 00000000UA0157 608263MR5W 00000290457MR1 608263MR6 00000296418MR7 608287MR1 00001052XF5031 608374MR 00000000HM0606 608775MR1 00000000UA0159 608775MR3T 00000307535MR5 608CHILDMR1 00000290957MR0 608HERIMR 00000288408MR8 608WAISMR 00000292528MR7 608WIMRMR2 00000299172MR7 609407MR 00000290659MR2 610740MR3 00000305910MR2 610997MRW 00000303645MR6 614257MR2 00000302194MR6 614566MR1 00000000UA0038 61456MR5 00000000UA0041 614GMC3T 00000303041MR8 614RMHMR3 00000303310MR7 615327MR450 00000296517MR6 615MTMR1 00000298420MR1 6162673T750 00000000UA0117 616267IMRI 00000298334MR4 616267MR450 00000298907MR7 616391450W 00000291363MR0 616391DVMR 00000298283MR3 616494DVMR 00000301469MR3 616774MR450W 00000000UA0030 616774MR750W 00000296640MR6 617726MR1A2 00000305451MR7 618288DVMR 00000298050MR6 618288OWMR 00000299645MR2 618997VAMR 00000000UA0075 619543HDMR4 00000306094MR4 623524MR1 00000300572MR5 630933MR3 00000000HM0484 630946MR1 00000299627MR0 631723MR450 00000305203MR2 631726MR450 00001301FMM03G 631968MR 00000303690MR2 636933JMR1 00000290137MR9 650723NCMR1 00000289309MR7 650723NCMR2 00000294472MR6 650723SSMR1 00000290704MR6 650723SSMR2 00000297374MR1 650PH3T 000000290605MR5 661KRMR750 00000305484MR8 662841MR5 00000000UA0147 671FHPMR750W 00000299264MR2 678565MR2 00000000HM0345 6970K 00000295134MR1 702616RDLMR 00000300968MR5 703205MR2 00000303773MR6 703205MR3 00000295111MR9 703391MR2 00000301599MR7 703573MR2DV 00000000UA0124 703698MR4 00000299683MR3 703805MR2 00000299544MR7 703805MR3 00000299181MR8 703858MR3T 00000304439MR3 704304DVMR 00000291980MR1 704384DVMR 00000304293MR4 704384MR450 00000305047MR3 704984DVMR 00000296829MR5 704CMCLMCMR 00000000HM0518 707521MR450W 00000303856MR9 707546MR450W 00000305485MR5 707651KVMR 00000300792MR9 707DG3T 00000000UA0050 708346MR3 00000000HM0708 713441MR6W 00000296114MR2 713441MR8 00000294398MR3 713441MR9 00000302796MR8 713566SMITH1 00000303439MR4 713566SMITH2 00000304167MR0 713566SMITH3 00001301FMM040 713792AMR13 00000299406MR9 713792CMR1 00000303614MR2 715623MRW 00000294718MR2 715838MR3T 00000300866MR1 715ADCMR1 00000306011MR8 716665MR1 00000296602MR6 7168453T 00000000HM0522 717975MR2 00000000UA0012 71872MR750W 00000299199MR0 719260MR 00000299331MR9 720321MR 00001250FMM02C 720708MR 00000302193MR8 720SAHMOBMR 00000304721MR4 724981MR450W 00000298574MR5 727462MR1 00000301126MR9 727834MR 00001251FMM00Y 731541MROP2 00000304319MR7 731644MR2 00000296860MR0 732249MR 00000302997MR2 732938MR 00001245FMM04T 7347633TMRFIX 00000000HM0612 757261mr 00000299200MR6 757312MR 00000000UA0099 757827MR2 00000294953MR5 7579533T 00000000HM0683 757953450WMR 00000000UA0141 757983MR 00000303767MR8 760452MR1 00000308080MR1 765362MR1 00001234FMM0J0 765448MR450 00000304168MR8 770252MR 00000299160MR2 770918GEMR 00000302434MR6 773525MR3 00000000HM0314 773792MRI 00000300985MR9 775SIERRAMR 00000297355MR0 775WNKAMR 00000296097MR9 781340MR2 00000300724MR2 781340MR3 00000304944MR2 781HV450MR 00000303777MR7 785623MR2 00000301869MR4 801262MR3 00000303778MR5 801268MR2 00000295112MR7 801377MR3 00000301228MR3 801475MR1 00000304852MR7 801535MR1 00000299294MR9 802371MR 00000304375MR9 803329DVMR 00000298722MR0 803434MR2 00000295092MR1 803434MRI 00000303637MR3 803751MR 00000304406MR2 804330MR450W 00000301379MR4 804WAT450 00000300732MR5 805687MR1 00001301FMM04Y 805898MR 00000305412MR9 805SCMR 0000000UA0032A 808485MR2 00000000UA0086 808545MR 00001251FMM01U 808873MR750W 00001227FMM00M 808HRAWMR 00001250FMM035 808YMMR 00000297974MR8 810235DVMR 00000298901MR0 810762MR 00000305522MR5 812265MR 00000294698MR6 812485MR3 00000300929MR7 813745MR2 00000306065MR4 814234MR450W 00000000HM0600 814237MR450W 00000304374MR2 814333MR450W 00000303855MR1 815215MR 00000300795MR2 815300MR1 00000000UA0048 815395MR2 00001251FMM03A 815399MR2 00000301156MR6 815664MR450W 00000301235MR8 815937MR 00000299559MR5 815971MR2 00000000HM0609 816276MRW 00000301378MR6 816561MRW 00000299515MR7 816698CP3T 00000296014MR4 816932DVMR 00000296040MR9 817321RATCMR1 00000304850MR1 817472TSMR1 00000299634MR6 817482BKMR1 00000303415MR4 818790MR1 00001118FMM0WD 828213MRW 00001101XF50B7 828213RMRW 00001106XF5016 828456MRW 00000301094MR9 828586MRW 00000298537MR2 832522MR1 00000300039MR5 832522MR2 00001236FMM01B 843390MR 00000296226MR0 843606MPMR 00001236FMM01W 843762CCMR 00001301FMM03V 843832SMR 00000298655MR2 845348MR 00001026XF5198 845368MRW 00001102XF506B 845454MR 00000300883MR6 845483MR 00000301198MR8 845794MRW 00000301260MR6 845943MR 00001012BD66BC 847618MR1 00001236FMM01F 847872ZMR1 00000000UA0139 847872ZMR2 00000299339MR2 847SAMCMR3 00001301FMM04E 850862MR1 00001250FMM023 850RA450W1 00001233FMM06X 856247MR1 00000304827MR9 856247MR2 00000000UA0092 856247MR3 00000000UA0146 856581MR3T 00000000HM0631 856768MR 00000305452MR5 858549HDMR1 00000000UA0118 858622HDMR1 00000950BD627C 858822HDMR1 00000301752MR2 858822HDMR2 00000944BD6172 858939MR3 00001106XF50A6 858939MR4 00001051XF5039 859301MR 00001102XF502F 859744MR450 00000304801MR4 860678450W 00000298248MR6 860749MR 00000301962MR7 863688MR 00000298310MR4 864225DVMR 00001050XF5015 864255SFMR 00001232FMM01T 864560DVMR 00001101XF50B8 864725MRI 00001049XF5011 864849DVMR 00000303692MR8 865525MR2 00000000HM0636 901384MR450 00000303765MR2 901726MR450 00000919BD5B82…

Recall started

April 23, 2014

Device type

System, Nuclear Magnetic Resonance Imaging

Root cause (FDA)

Process design

What the company told customers

Consignees were sent on 4/23/2014 a GE Healthcare Ref # 60863 "Urgent Medical Device Correction" letter dated April 18, 2014. The letter was addressed to Hospital Administrators / Risk Mangers, Radiology Department Mangers and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. If customers encounter the stated problem with the device, they should contact their GE Healthcare Service Representative for an inspection and necessary repairs. GE will correct all affected devices at no cost to the customers. For questions customers should contact their local service representative.

Recall number

Z-1533-2014

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1533-2014. The agency record governs; check it and the company before acting.