GE Healthcare…

Date

Oct. 23, 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, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for general purpose diagnostic fluoroscopy and radiography studies.

Reason

GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular X-ray imaging systems.

Distribution pattern

Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and except ND, SD and VT, and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA ARICA, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY,GREECE, GUADELOUPE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN,IRELAND, ITALY, JAMAICA, JAPAN,JORDAN, KAZKHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LIBYA ARAB JAMHIRIYA, LITHUANIA, MALAYSIA MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SLOVAKIA, SPAIN, SWEDEN, SYRIA, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UKRAINE, UNITED KINGDOM, and VENEZUELA.

Quantity

2184 (1063 US. 1121 OUS)

Codes and lots

Mfg Lot or Serial # System ID 00000026767YY4 201982LCA 00000068001YY7 901384LCA 00000033988YY7 914737LCA 00000034024YY0 954LCA1 00000031679YY4 708216LLCA 00000952037WK0 630856LCN 00000320794BU1 082406010002 00000346260BU3 DR-27820-CO 00000991021WK7 LB1160VA01 00000058879BU8 930047946 00000484712WK5 1453 00000529468WK1 915685LCA 00000528385WK8 082406040003 00000526149WK0 66324TC 00000497670WK0 M4017051 00000512202WK3 1616LCA 00000528587WK9 62134LCV+ 00000533252WK3 00001VAS01 00000548229WK4 506857LCA 00000088970BU9 0910063030 00000233847BU3 082406030001 00000238390BU9 083016598280384 00000245186BU2 RU1488RX20 00000249068BU8 34090VAS01 00000023887YY3 205599LCV 00000055095YY4 207283LC1 00000030139YY0 210428VCATH2 00000023954YY1 212604LC2 00000048123YY4 212604LCA2 00000048175YY4 214376VADV1 00000034312YY9 215576LC2 00000063851YY0 215662LCLP1 00000034351YY7 215955LCEP 00000034379448 216343LCA 00000026282YY4 216363LC 00000023914YY5 216384LCA 00000034355YY8 304256RCL1 00000055081YY4 304487LCA 00000048177YY0 305223LCV 00000023959YY0 305325LCA 00000063853YY6 307577HCL1 00000034352YY5 317818MDI111 00000055057YY4 317818MDI170 00000026283YY2 318462BCL 00000048183YY8 352333ANGIO 00000034327YY7 404991LCA 00000048150YY7 405271UC1 00000063859YY3 405359ELCV 00000023910YY3 407646CL1 00000034390YY5 409532GLCV 00000026316YY0 412578DLX 00000034341YY8 415540ADVLCLP 00000055053YY3 423493PSL 00000048145YY7 440585LCA 00000055092YY1 440835LCA 00000034383YY0 502587SP2 00000022054YY1 502933CL2 00000026276YY6 504380ADV1 00000048128YY3 540596LCV 00000034375YY6 561650LCA 00000030105YY1 601865ADY 00000030168YY9 615544LCA 00000034306YY1 615977SP 00000023934YY3 619340VA6 00000023871YY7 619347LC 00000030130YY9 619457SCL 00000026303YY8 619457SCL2 00000034347YY5 619739LC 00000055077YY2 661282CCLV 00000063864YY3 661326CATH1 00000030134YY1 704456LCV 00000034300YY4 707546ANGIO 00000030126YY7 717782LC1 00000034372YY3 717969LCC 00000030128YY3 718270LC 00000055052YY5 727521LCV 00000034376YY4 806358LCA 00000026272YY5 813462CATH 00000023936YY8 813586ADV1 00000055074YY9 828255MV5 00000030190443 903236LCA 00000034365YY7 904739CV2 00000048167YY1 904MHWCL 00000026290YY7 909387LCV 00000023920YY2 910343NHC1 00000026287YY3 910716BCL2 00000034391YY3 941629LCA 00000055059YY0 941798CATH1 00000048146YY5 972548CATH 00000048139YY0 CSI104 00000048156YY4 CSI106 00000026288YY1 DLPGMH1 00000022064YY0 M27036 00000039134YY1 704456LCV 0000048177YYO0 305223LCV 00000550095YY4 207283LC1 00000022059YY0 609757CCL3 00000026273YY3 813462CATH 00000030111YY9 801350LC2 00000030144YY0 908324CATH 00000022065YY7 1077 00000023879YY0 87373-1 00000023925YY1 082416170001 00000023960YY8 EG1005VA03 00000030181YY2 E4167601 00000048199YY4 M2147228 00000048102YY8 HC1251XR01 00000063868YY4 0835060003 00000063919YY5 IR1495VA01 00000063895YY7 A5111122 00000063910YY4 A5183634 00000048174YY7 A5214921 00000063921YY1 A5365407 00000063917YY9 A5367508 00000063920YY3 A5401513 00000063901YY3 C5120901 00000063877YY5 YX1122 00000063902YY1 YX1140 00000063894YY0 YX1185 00000063913YY8 YX1233 00000063912YY0 YX1314 00000063891YY6 LB1018VA01 00000026296YY4 LB1049VA02 00000030154YY9 LT4000VA02 00000034373YY1 14231LC 00000023958YY2 2235LCV 00000030151YY5 WRT0102 00000023942YY6 SA1000VA01 00000063880YY9 CE229631 00000063882YY5 FEB52037 00000063875YY9 YP629705 00000048103YY6 0853060152 00000048166YY3 0853060155 00000030115YY0 06008VAS02 00000023838YY6 215221CL1 00000063798YY3 303320CL1 00000063779YY3 303320CL2 00000063791YY8 312792RINOV2 00000022078YY0 314768SMLC 00000031479YY9 423493PCL1 00000023794YY1 516351LCA 00000048001YY2 516663LC3 00000031441YY9 603668CLC3 00000048085YY5 706354SLCA 00000031410YY4 708259NWLCA 00000048098YY8 765646CL1 00000048083YY0 770389LCA 00000063721YY5 909865LCLP 00000023830YY3 912633MCL1 00000063805YY6 BPEP 00000063736YY3 MCTHKGMN 00000022073YY1 215537LUA 00000023851YY9 501972SBL2 00000031458YY3 904739CV2 00000023773YY5 1001 00000023795YY8 1021 00000023777YY6 1025 00000023778YY4 1031 00000026180YY0 6227 00000022169YY7 86940 00000023852YY7 87650 00000023841YY0 93162 00000026217YY0 94788 00000023770YY1 1070 00000023855YY0 1021 00000026223YY8 082406120004 00000022095YY4 082406140002 00000026183YY4 082406220002 00000022088YY9 YU4006VA02 00000026260YY0 DEN27227 00000026135YY4 203325LCV 00000047978YY2 205329LCV 00000089619MO1 205592MLC 00000113966M06 219757INVA 00000026090YY1 304348LCA 00000128484M03 312CCHGECATH 00000023746YY1 314577ULCA 00000031342YY9 505848LCA 00000128617MO8 516562INNOVA4 00000128539MO4 563421CATHLAB6 00000063483YY2 601288CV3 00000034255YY0 601288CV4 00000052196YY3 601459LC 00000052199YY7 615264LCV 00000080070YY6 615769SKYCV1 00000071213YY3 615778ESPL2 00000034209YY7 718403LC 00000052138YY5 740446LCA 00000063620YY9 843797LCA 00000052178YY1 914632LCA 00000063533YY4 915649LCV 00000063506YY0 919443NGLCA 00000128531M05 973365LAB1 00000034271YY7 973429CATH 00000118197MO3 973971LAB4 00000113950MD0 973971LAB5 00000022202YY6 314768SMLC 00000023729YY7 910343NHC1 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00000063983YY1 YX1438 00000063967YY4 BRD0409 00000043949YY7 PER42000 00000043900YY0 SA1003VA03 00000063971YY6 YP170A12 00000033908YY5 201365LCA 00000026763YY3 201625LCA 00000071104YY4 212604EP1 UNK21320850001 212639LCA 00000071115YY0 228575LCA 00000045551YY9 303450LCA 00000033948YY1 303673LCA 00000047646YY5 303695LCA 00000033964YY8 305682LCA 00000034000YY0 313421LCA 00000034031YY5 314933JMA 00000026716YY1 318388CLCA 00000047612YY7 318675LCA1 00000033980YY4 318681SLCA1 00000047645YY7 501484LC2 00000068006YY6 502587LCV6 00000033918YY4 502875LCA 00000033998YY6 504230LCA 00000047604YY4 504873TSP 00000068036YY3 513870LCA 00000026691YY6 518761GLCA 00000071140YY8 561798LCA 00000033968YY9 601234LCA 00000047686YY1 601268WSP1 00000047676YY2 603432PSP 00000034017YY4 606252LCA 00000047626YY7 606268LCA UNK21320850000 704384LCA2GS 00000026726YY0 706647LCA 00000034029YY9 717346LCA 00000025866YY5 718876LCA 00000033989YY5 718963LCA 00000047684YY6 727341LCA 00000033951YY5 757889RM9 00000033911449 801350LCA 00000025823YY6 804281ANGIO 00000026693YY2 813462ADV1 00000045572YY5 850494WSP2 00000026758YY3 864455GMSR9 00000068003YY3 901661LCA 00000047608YY5 901726M2LCA 00000047621YY8 908527LCA 00000034032YY3 909243AVTX 00000033930YY9 912757LCA 00000047507YY7 CSI105 00000057366YY7 CSI202 00000057385YY7 CSI203 00000068017YY3 CSI204 00000068018YY1 CSI205 00000080217YY3 CSI209 00000080240YY5 CSI210 00000080218YY1 CSI214 00000047687YY9 ECXV1407CLCV 00000034009YY1 336293LCA1 00000071140YYB 561798LCA 00000024987YY0 602258TILT 00000025012YY6 708259NWLCA 00000025828YY5 314577ULCA 00000025853YY3 205877BSPXXX 00000026690YY8 304348LCA 00000026755YY9 505848LCA 00000033911YY9 801350LCA 00000033961YY4 718403LC 00000033975YY4 404991LCA 00000034021YY6 601288CV4 00000034033YY1 973429CATH 00000034049YY7 216343LCA 00000045599YY8 CSI104 00000047647YY3 914632LCA 00000047655YY6 CSI106 00000047669YY7 601459LC 00000047683YY8 919443NGLCA 00000047693YY7 601288CV3 00000057371YY7 740446LCA 00000071116YY8 843797LCA 00000033945YY7 17883ADVLC 00000045573YY3 0364060001 00000080220YY7 35272 00000033997YY8 11597 00000080201YY7 17815 00000047639YY0 23040 00000045561YY8 29306 00000047633YY3 31249 00000045570YY9 40869 00000068007YY4 43035 00000068043YY9 48776 00000045571YY7 49840 00000071139YY0 56719 00000068040YY5 85480 00000068039YY7 85544 00000071123YY4 90690 00000034001YY8 99299 00000068014YY0 74704-1 00000024999YY5 416522LCA 00000071134YY1 082406020001 00000071168YY9 082406020002 00000068046YY2 082406040005 00000071178YY8 082406040020 00000047668YY9 082406050004 00000006800YY9 082406070001 00000071161YY4 082406090002 00000071171YY3 082406090005 00000068026YY4 082406100004 00000071137YY4 082406120001 00000068034YY8 082406120005 00000057382YY4 082406120007 00000071186YY1 082406120009 00000071133YY3 082406140008 00000047662YY2 082406160001 00000047698YY6 082406160007 00000071113YY5 082406160008 00000071183YY8 082406190002 00000047643YY2 082406210002 00000057397YY2 082406210005 00000026771YY6 082406210008 00000047674YY7 082406220003 00000033900YY2 082406250001 00000071148YY1 082406270001 00000071167YY1 082416010001 00000071136YY6 082416160001 00000068041YY3 082416200001 00000068000YY9 082406070001 00000026765YY8 M4486917 00000047653YY1 X2881402 00000033957YY2 GE1000VA01 00000071143YY2 H2077VAS04 00000071157YY2 H2077VAS05 00000068009YY0 H2197VAS09 00000068035YY5 083006592809757 00000034040YY6 IR1063VA02 00000047618YY4 IE1031VA01 00000033937YY4 A5140610 00000071122YY6 YX1128 00000071147YY3 YX1148 00000071159YY8 YX1183 00000071160YY6 YX1184 00000057372YY5 LB1071VA01 00000047610YY1 0834060006 00000047666YY3 MQ1008VA01 00000071173YY9 600123VA01 00000033926YY7 RU1041VA01 00000026769YY0 RU1298VA01 00000047677YY0 RU1556VA01 00000071188YY7 RU1734VA01 00000026768YY2 NE222872 00000034020YY8 NP335806 00000047644YY0 0853060157 00000057374YY1 0853060161 00000071172YY1 0853060164 00000071191YY1 0853060168 00000047601YY0 0853060162 00000057398YY0 0853060157 00000071176YY2 38824624VASOCC 00000080202YY5 38831231VASCTR 00000031708YY1 1751 00000031703YY2 502793G5 00000031740YY4 516968LCV 00000031683YY6 615781LCA 00000031650YY5 203325LCV 00000031655YY4 909387LCV 00000031707YY3 516663LC3 00000031711YY5 212604LCA2 00000031736YY2 615264LCV 00000031738YY8 423493PSL 00000031686YY9 23767 00000031723YY0 604631LCA 00000031728YY9 EG1102VA01 00000031672YY9 NO1000VA01 00000031670YY3 PER18103 00000031676YY0 A020RX06 00000234478BU6 212746L511 00000225366BU4 YX1456 00000000824MC3 303436LCLP 00000120399M01 303778CL1 00000120399MO1 303788SP3 00000120418MO9 412647LABD 00000131446M07 415600LCALP 00000120404MO9 504897ADV3 00000000113MC1 516663EP2 00000000793MC0 609757LCEP 00000131448MO3 615284CV1 00000131456MO6 617525LCN 00000000190MC9 619543UC6 00000000287MC3 717763EP1 00000120440MO3 718780EP 00000120441MO1 806212SPEC 00000120407MO2 815226INN1 00000000132MC1 901726SP1 00000000188MC3 904739EP 00000000565MC2 BPANGIO 00000000288MC1 FHORLCL6 00000000089MC3 563421CATHLAB6 00000000562MC9 BPEP 00000120425MO4 312CCHGECATH 00000000186MC7 010120RX40 00000120403MO1 418656CLCLP 00000131447MO5 A1105902 00000000718MC7 B1607012 00000000156MC0 A5109211 00000000095MC0 A5109212 00000000563MC7 A5267808 00000000794MC8 C5821416 00000120411MO4 YX1449 00000120437MO9 YX1458 00000000434MC1 YX1462 00000120396MO7 YX1515 00000000217MC0 YX1520 00000000719MC5 YX1700 00000120438MO7 LB1040VA01 00000131450MO9 MA1070VA01 00000000203MC0 MA1272VA01 00000120442MO9 0853060175 00000131451MO7 0853060176 00000000388MC9 0853060180 00000000157MC8 0853060182 00000000158MC6 0853060182 00000120431MO2 00243VAS01 00000289997BU9 YX1192 00000305717BU1 SA1039VA01 00000273885BU4 DLP069 00000252139BU1 1322875LCV 00000258324BU3 H2197VAS10 00000265561BU1 A5162231 00000266866BU3 B5820845 00000277196BU2 317818MDI925 00000294681BU2 082406040007 00000305325BU3 082406040010 00000293076BU6 082406090004 00000282496BU9 082406110002 00000294682BU0 082406150001 00000284078BU3 082406190001 00000302110BU2 082406240001 00000272431BU8 EG1914VA01 00000294680BU4 083016824542X…

Recall started

Aug. 16, 2013

Device type

Interventional Fluoroscopic X-Ray System

Root cause (FDA)

Process control

What the company told customers

Consignees were sent on 8/12/2013 a GE Healthcare "Urgent Medical device Correction" letter dated August 12, 2013. The letter was addressed to Hospital Administrators / Risk Mangers, Mangers of Radiology /Cardiology /Surgery Department and Radiologists /Cardiologists /Surgeons. The letter described the Safety Issue, safety Instructions, Affected Product details, Product Correction and Contact Information (US 800-437-1171, Japan 0120 055 919).

Recall number

Z-0021-2014

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

Source: FDA · Medical device enforcement report, recall number Z-0021-2014. The agency record governs; check it and the company before acting.