GE Healthcare Quasar Nuclear Medicine System…

Date

April 17, 2013

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 Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems, all configurations.

Reason

Accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomography System could result in mechanical failure causing the detector to slide; may impact patient and operators.

Distribution pattern

Worldwide Distribution - USA (nationwide) including DC and PR and the countries of UKRAINE, TAIWAN, TURKEY, TUNISIA, THAILAND, SINGAPORE, SWEDEN, SAUDI ARABIA, RUSSIAN FEDERATION, PORTUGAL, POLAND, PAKISTAN, PHILIPPINES, PANAMA, NEW ZEALAND, NORWAY NETHERLANDS, MALAYSIA, MEXICO, MALTA, MARTINIQUE, MOROCCO, LATVIA, LITHUANIA, LEBANON, KUWAIT, KOREA, JAPAN, JORDAN, ITALY, IRAN, INDIA, ISRAEL, IRELAND, INDONESIA, HUNGARY, CORATIA, HONG KONG, GREECE, GEORGIA, UNITED KINGDOM, FRANCE, FINLAND, SPAIN, EGYPT, ECUADOR, ALGERIA, DOMINICAN REPUBLIC, DENMARK, GERMANY, CZECH REPUBLIC, CYPRUS, COLUMBIA, CHILE, SWITZERLAND, CANADA, CHINA, BRAZIL, BELGIUM, AUSTRALIA, AUSTRIA, ARGENTINA, SOUTH AFRICA, VENEZUELA, URUGUAY, ALGERIA.

Quantity

2180

Codes and lots

System ID (As required) 787764INFINIA-1 SA2146NM01 TN1366NM01 SA1001MN01 PK1031NM01 PK1032NM01 PK1180NM08 PK1184NM01 PK1307NM01 PK1336NM01 MA1439NM01 LB1122NM02 KW1013NM01 KW1013NM02 KW1018MN06 KW1018MN08 EG1124MN02 323268INF1 630312INF 630545INF 630856INF 630275INF 330344INFINIA1 518262INF1 518262INF2 518262INF3 724226INF1 ARHINFI 610770INFINIA 502893INF 443481BINF 443481INF 443481INF2 661949NUC1 804594INF1 480323INFRM1 607737INF 404265INF 330363INFINIA 920451INF 920907INF 305682INF1 602588INF 904821INF3 904821NM1 904821NM2 615284INF1 904627INF2 904321INF1 904202INF1 501202INF 662244INFINIA 225381INF 972394INF 727863INF1 713359INF1 419483NUC2 406731INF1 228436INF 865977INF 804281INF1 804225INF1 941VRMCINF 248471INF 203384INF 269657SHINF 718240INF2 718240INF1 BCHINF1 513454INF1 843402INF2 843606INF1 609730INF1 GILESINF 217554CINF 843674IN1 843674IN2 843674IN3 704225INF1 704355INF1 704355INF2 704863INF1 770382INM 973877INFINIA 859313INF 423625INFINIA 859498INF1 937440INF2 606878INF1 606878INF2 512528NM1 305325INF 615342INF1 816380CASSINF 816392RINF 816836CIIN SLGHINF 207795INFINIA 518562INF 757312INF1 757312INF2 410337INF3 973831INFINIA 708684INF1 302733INF 318681INFINIA2 281599INF1 805489INF1 352344INF 256327NUC 704487INFINIA1 718948INF 843782INF 931403NM1 256429INF1 CFRHINF 727521INF 904276INF1 702255INF 210617NM1 847990INF1 814533INF2 814534INF 607756INF 607756INF2 740623INFINIA 319272INF CRAVENINF2 CRAVENINF3 CRAVENINF1 618544INF 402449INF 337436INF 318798INFINIA 203797INF 304637INF 205750INF 205759INF 256341NRM1 760778INF1 702369NM 760241INF1 850883ENM 904542NM 502624INF 727581INF 630786INF 786308INF1 786308INF2 214324INF 919684INF3 318330INF1 843412INF 504454INF 303837INF 330721INFINIA1 330721INFINIA2 502350INF 904819INF1 928214INF FHEINF 954735INF2 813788INF1 225647INF 318327INF1 318388INF1 601288INF1 865373INF 865429INFINIA 240566INF 256494NM1 316858GI 662256INFINIA 561650INF1 843692IN1 319768INF 319768INF2 770229INF 979532INF1 706278INF 828586INFINIA 262670INF2 978521INF 517543INF 727942INF 256386HKNM2 906293INF 618942INF 305835INF 847480INF 843689INF 605353NM 435251INF1 801357INF1 701364INF 703858INF 815432INFINIA 814643INF 773947INF 570398INF 502955INF 859268INF1 502259INF 732321INFINIA 954265INF1 561744INF 305227INF1 305227INF2 262656INF2 513867INF 441236INFINIA 704739INFI 281348INF 307332INFINIA 225658INF 772LMCNM2 901287INF1 LGMCINF 304831LNM1 951672INF1 805737INF1 805370INF1 304623INF1 304623INF2 609835INFINIA 707822INFINIA 409938INF 828696INFINIA1 252436INF1 415925INF 925779IN 740383INF1 843431IN 402461INF 931381NM2 843777IN1 843777IN2 814333INFINIA1 814333INFINIA2 478633INFINIA 732840INFINIA 580931INF1 727843INF1 815756INF 609267INF 713242INF2 713242INF3 432685DNUC 812522INF MVINFNM2 913345INF1 209385IN 419455INF1 701774NM 281274INF 402354INF 832522INF 832522INF2 614478INF1 615349NM1 615349NM2 860344INF 662772INFRM1 662772INFRM2 662772INFRM4 405610MINF1 617313INF1 603924INF 973971INFINIA 212241INF2 801465INF1 302629INF NASHNM2 601443INF1 518773INF 239NCHINF1 281897INF1 212608INF1 COR373273 COR373282 617243INFINIA 405307INF1 352333INF 225NOINF 985230INF 770219INF 770535INF1 210757NM1 215537INFINIA 985646INF 479751INF 954978INF1 203852INF 704316INFI 516IPKINF1 352596INF1 708660INF 734467INF 734671INF 228818INF 885INFI1 885INFI2 478454INF 801479INF 801479INF2 ORMCINFINIA2 OBNM1 913541INF1 908522INFINIA2 908522INFINIA3 417256INF 661PMCNUC1 845987INFINIA 435658INF 423493PINF 803329INFIN1 PITTINF5 571231INF1 571231INF2 610327INFINIA 303839INF 815432INF 248849INF1 248849INF2 903785INF 505863INF 816348INF1 804254INF 618395INF 601936INF1 732530INFINIA 256543INF1 325235NUC 843402INF 843724INF2 773995INF 828286INFINIA 920849INF 918494INF2 918494INF3 918502INF1 501776INF 518271INF 310832INF1 502868INF1 480882INF2 435893INF 951696INF1 818907INF1 805543INF1 479524INF 605333INF2 985649INF1 985649INF2 856363INFINIA 404466INF 229259INF 229333ICINF1 229333ICINF2 912691SCNC 918294INF1 610869INF 615781NM1 301877INF 740356INF2 931967NM 804957INF1 804957INF2 616267INFINIA 540498INF1 828766INFINIA 504537INF 815395INF 309344SMNUC 217347INF2 217347INFINIA 985785INF 412343INF1 618234INF1 918307INF1 901765INFRM8 864675INFI 516562INFINIA2 309655INF1 708747INFACQ 225INFINIA 313343INF2 313343INF3 313343INF4 217544NUC1 773665INF1 773665INF2 765456INF 813870INF 410337INF2 602406INF 602406OPINF 281251SLVINF 713785SLINF2 610954INFINIA 281637INF 479967INF 580249IN1 409985NMI1 812485INF 214879INF 814452INF1 205408INF2 317415INF 912486EGNC 405742INF1 615328NM1 504380INF 504873INF2 404686INF 573686INF2 662423INFINIA 828883INFINIA 734475INF 903731INFINIA 918307INF2 570836INFINIA 310319INF1 806354NWINF 330343INFINIA 704225INF2 724450INFINIA 607762INF 681342INF1 681342INF2 681342INF3 681342INF4 434924INF1 434924INF2 434924INF3 913588INF1 774442INF 618256INF1 817472INF 208422INF 254743NM2 713794INF3 541440INF 269223VABCINF 906774INF 618993INF 757722INF1 509473INFINIA 702388VNM 910323INF1 970945INF 706733INF 478272INF 419238INF 210MTINFINIA 316268VCFI2 814723INF 479463INF 479463INF2 828262INFINIA 856247INF 623882INF 620225WPI 262687INF2 248898INF 248898INF2 757259INF1 814467INF 713722INF 817346INF 512324NM 210705NM1 765552INF 740264INF4 740264INF3 630275INF2 818884INF1 UK5002NM01 0853260023 0853260066 0853260074 0853260046 0853260056 0853260039 0853260087 0853260024 0853260045 0853260069 0853260042 0853260072 0853260062 0853260020 44014NUC01 06109NUC01 34318NUC01 01012NUC01 17005NUC01 21011NUC01 35003NUC04 23003NUC01 34284NUC04 45011NUC01 34335NUC01 23002NUC01 06008NUC09 06051NUC01 41009NUC01 52006NUC01 34017NUC01 07015NUC01 34094NUC02 63009NUC01 38001NUC01 38001NUC02 00013NUC01 01042NUC01 34021NUC02 34340NUC01 34351NUC01 0856260029 0856260031 0856260026 0856260028 0847260025 0002765581 A004NU11 Y004NU11 PPR12213 PPR59030 PMR12506 PPS06907 PK1001NM01 0843260034 0843260037 0843260044 2565059INFINIA NO1000MN06 HGV0130 GOU0137 GOU0138 HDB0130 MPP0131 MT1014NM01 MT1014NM02 MQ1000MN04 LT4000MN01 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A5315551 A5113627 A5178021 B5395703 C5120912 A5924402 A5109665 A5109666 A5216824 A5162248 A5352208 D5111607 A58080111 A58080134 A5111240 A5215935 A5129026 A5267107 A51043155 A51043187 A51152163 A51152164 B5365422 083026602101669 083026802101686 083026801003210 083026602101279 083026002002289 IL1069NM06 IL1068NM05 IL1018NM07 IE1006MN04 HU1099NM01 HR4103NM01 05452NUC03 00271NUC04 00624NUC01 00624NUC03 00116NUC01 00186NUC02 IE1564NM03 00289NUC02 00203NUC03 00231NUC09 00165NUC04 IE1510MN09 00669NUC01 00169NUC07 10497NUC01 00440NUC11 00440NUC07 70027NUC03 00171NUC04 77624NUC01 77624NUC03 V1471114 V2943415 V7406615 V7405209 M4159227 M4159228 M4018536 M4163763 M4018099 B5483443 A4169304 M8572211 M1400803 M4024095 A4194407 X105967813 M2269829 V2728105 M4167153 M218669001 M4211068 M5172527 X61014001 X100611101 M4023087 M9886832 M1279727 M4480232 M1804913 M4135141 B4182004 M4234232 M4234235 M4479619 M44827146 E4858901 M4144332 P4211482 R4211480 M9162716 X59007307 M7411106 X2034002 X151957601 S4160059 M4040544 M4215553 X4211026 FE443890 DE539254 UEW19003 UEW19005 MPX46902 DEN01721 DEN01727 UPW00402 GPQ19105 ME051533 UE720407 MPX82204 MPX47106 EG1826MN01 DK1023NM05 HC7475NU03 HC0842NU01 CHAM01NU01 UC7655NU03 HC0507NU03 HC1249NU01 HC1249NU02 493519NU01 PC1818NU03 PC8118NU01 HC1819NU01 CC3899NU01 HC3442NU01 HC0892NU04 HC4387NU02 2583615INF 2928217inf 262010NU01 475290NU01 529150NU04 905683IN1 613969INFINIA 819537INFINIA 819537INFINIA2 416928INFINIA 709737INFINIA 204837IN1 416813INFINIA 416444INFINIA1 905855INFINIA2 905855INFINIA3 905472INFINIA 905832INFINIA 613727INFIN 514934AINFINIA 416756INFINIA2 905773INFINIA1 905845INFINIA1 705759INFINIA2 403777INFINIA3 306655INFINIA2 306655INFINIA4 905895INFINIA1 905895INFINIA2 905522INFINIA 905522INFINIA2 705674INFINIA 519965INFINIA 905848INFINIA 250727INFINIA1 082426040034 082426040035 082426270006 082426190016 082426140020 082426140021 082426120006 082426120017 082426040037 082426110007 082426140017 082426150022 082426040033 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740356INF1 210921NM1 415222IN1 205408INF 203325INF 203325INF2 504873INF 573686INF1 907562NM1 540213INF1 601978INF 956350NM1 316962WI 01002NUC04 0856260025 O005NU14 Y004NU08 H002NU01 PPR08202 0843260029 2543334INFINIA YN1200 A5153612 A5197927 C5120915 A5172907 A5118056 083026862101014 083026602101643 083026862100874 083026822100376 IE1100MN01 IE1029MN05 IE1053MN01 HU1039NM02 0828260003 0828260005 00109NUC01 00253NUC02 00216NUC11 00260NUC03 00348NUC02 IE1510MN12 00331NUC02 UE282633 YE364413 783348NU01 450654INF2 709651INFINIA 604520INFINIA1 604520INFINIA2 519749INFINIA 418275INFINIA 905731INFINIA 905855INFINIA 416633INFINIA 416756INFINIA 905372INFINIA 705759INFINIA 306766INF2 306766INF1 306655INFINIA 519631INFINIA 604588INFINIA1 604588INFINIA2 604278INFINIA2 604875INFINIA1 082426040030 082426210013 082426120011 082426200003 082426150012 082426130025 082426130020 082426160025 082426080010 082426100028 082426030020 082426120007 082426030021 082426130024 082426080012 082426130021 082426310015 082426160026 082426050004…

Recall started

March 6, 2012

Device type

System, Tomography, Computed, Emission

Root cause (FDA)

Process control

What the company told customers

GE Healthcare sent an " IMPORTANT PRODUCT INFORMATION" letter dated March 6, 2012. The letter was addressed to Managers of Nuclear Medicine, Hospital Administrators / Risk Managers and Managers of Radiology/Cardiology. The letter described the Issue, instructions, Affected Product Details, and Product Correction. For questions contact your local GE Healthcare Service Representative or call the GE Healthcare Call Center: United States or Canada: 800-437-1171 and Other Countries 262-896-2890.

Recall number

Z-1078-2013

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

Source: FDA · Medical device enforcement report, recall number Z-1078-2013. The agency record governs; check it and the company before acting.