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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Optima CT540

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  Class 2 Device Recall GE Healthcare Optima CT540 see related information
Date Initiated by Firm April 27, 2018
Create Date August 17, 2018
Recall Status1 Terminated 3 on August 21, 2020
Recall Number Z-2872-2018
Recall Event ID 80563
510(K)Number K082816  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.Sold under the following product names:
BEIJING CT OPTIMA 540, BEIJING OPTIMA, BEIJING OPTIMA 540, BEIJING OPTIMA 540 ASIR, CT BEIJING OPTIMA 540, CT BEIJING OPTIMA 540 ASIR, CT GOLDSEAL OPTIMA 540, CT OPTIMA 540, CT OPTIMA 540 ASIR, CT OPTIMA CT540 TANG BEIJING, DISCOVERY 670 3/8 MEA PRO, HINO OPTIMA 540, HINO OPTIMA 540 ASIR, HINO OPTIMA 540 ASIR, OPTIMA 540, OPTIMA 540 ASIR, OPTIMA 540 MOBILE BEIJING, OPTIMA CT540,
OPTIMA CT540 32 SLICES, OPTIMA CT540 ASIR, OPTIMA CT540 BJG SKD RUSSIA, Optima CT540 Gantry Top Asm with Rating Plate,SGB tube and CJ cover, Optima CT540 Gantry Top Asm with Rating Plate,SGB tube and CJ cover for Hino, OPTIMA CT540 TANG, OPTIMA CT540 TANG BEIJING, OPTIMA CT540 TANG HINO
Code Information Model Number, Serial Number (System ID):   5432539, 00000409871HM1 (IR1304CT02);  5432539, 00000406425HM9 (IR1563CT01);  5432539-2, Not Available (970GMCT1);  5432539-2, 343769HM6 (262434OPTCT1);  5432539, 383019HM7 (251809DWMCT);  5432539-2, 00000058405YC2 (928289CT);  5432539, 00000340698HM0 (TMCACT540);  5432539, 340698HM0 (AM16OG71165);  5432539, 377682HM0 (850314CT);  5432539, 00000333256HM6 (954916OPT16);  5432539, 00000350436HM2 (912466OCT);  5432539, 00000354310HM5 (770382ERCT);  5432539, 00000361670HM3 (919956CT);  5432539, 00000370798HM1 (704403KAN);  5432539, 00000358402HM6 (910642CT2);  5432539, 00000348412HM8 (SJRCT540);  5432539, Not Available (631367OPTMA);  5432539, 00000350435HM4 (803632CT16);  5432539, 00000377063HM3 (901516SCT2);  5432539, 00000353930HM1 (214276CT);  5432539, 00000358081HM8 (806592OPT);  5432539, 00000339268HM5 (817465PORT);  5432539, 397568HM7 (713MMRINWCT);  5432539, 00000348790HM7 (281949CF04);  5432539, 00000369111HM0 (713461MMCT);  5432539, 00000339269HM3 (571367OP540);  5432539, 00000359124HM5 (304526OPT540);  5432539, 00000341572HM6 (DZ1547CT01);  5432539, 00000394557HM3 (DZ1728CT01);  5432539-3, CBAQG1500007HM (DZ1865CT01);  5432539-3, 00000405602HM4 (83133304751);  5432539, 00000363481HM3 (BG4616CT02);  5432539, 00000343768HM8 (CM1059CT01);  5432539, 00000332406HM8 (416756BSCT);  5432539, 00000377064HM1 (M2521010);  5432539, 00000361671HM1 (D1215120);  5432539, 00000370797HM3 (M2800925);  5432539, 00000366018HM0 (M4490802);  5432539, 00000376544HM3 (83016600022314);  5432539, 00000370242HM0 (83021606244414);  5432539, 00000385348HM8 (83021602972314);  5432539, 00000368120HM2 (83021600006814);  5432539, 00000358080HM0 (83021606209314);  5432539, 00000370243HM8 (83021600015914);  5432539, 00000373336HM7 (83021606244714);  5432539, 00000385635HM8 (83021601345114);  5432539, 00000368121HM0 (83021600006914);  5432539, 00000357150HM2 (83021605910114);  5432539, 00000401157HM3 (83021606820815);  5432539, 00000403508HM5 (83021606956115);  5432539, 00000406408HM5 (IR2047CT01);  5432539, 00000406407HM7 (IR2062CT01);  5432539, 00000379352HM8 (IR1667CT01);  5432539, 00000410657HM1 (IR1049CT05);  5432539, 00000353278HM5 (IR1632CT01);  5432539, 00000390579HM1 (IR1574CT01);  5432539, 00000415100HM7 (IR1984CT02);  5432539, 00000397569HM5 (IR1662CT02);  5432539, 00000320014HM4 (A5940819);  5432539, 00000397401HM1 (A5178412);  5432539, 00000356471HM3 (A5812308);  5432539, 00000381107HM2 (A5805537);  5432539, 00000394558HM1 (A5129827);  5432539, 00000360894HM0 (MQ1009CT01);  5432539, 00000347506HM8 (MA1337CT02);  5432539, 00000387454HM2 (MA1513CT01);  5432539, 00000343767HM0 (MA1510CT01);  5432539, 00000349633HM8 (NG1111CT01);  5432539-3, 000005432539-3 (RO1304CT01);  5432539, 00000336741HM4 (RU0002CT01);  6447929, 00000457907HM4 (RU5124CT01);  6447929, 00000454683HM4 (RU9764CT01);  5432539, 00000367182HM3 (RW1039CT01);  5432539, 00000366655HM9 (RW1028CT01);  5432539, 00000367184HM9 (TN1674CT01);  5432539, 00000348791HM5 (06149CTS03);  5432539, 00000346181HM1 (34402CTS01);  5432539, 00000348052HM2 (34401CTS01);  5432539, 00000338324HM7 (251275GHCTOP540);  5432539, 381694HM9 (334418LS16);  5432539, 00000326335HM7 (305662CTOP);  5432539, 00000337348HM7 (850325OPT540);  5432539, 386853HM6 (1356380);  5432539, 00000342972HM7 (404785KCT);  5432539, 00000383021HM3 (217876CT540);  5432539, 00000325782HM1 (317890CDIW);  5432539, 00000320796HM6 (317569CDINE);  5432539, 00000322703HM0 (317846CDINCT);  5432539, 00000325273HM1 (317890CDIS);  5432539, 00000318100HM5 (765447CDICT);  5432539, 386852HM8 (812847GCCT);  5432539, 00000341570HM0 (620257CT540);  5432539, 00000328883HM4 (606573O540);  5432539, 00000317657HM5 (859313TCCT);  5432539, 00000360226HM5 (337468OP540);  5432539, 00000331902HM7 (651294OPT);  5432539, 394559HM9 (601645FCT);  5432539, 00000357149HM4 (704CMCHCT);  5432539, 00000340245HM0 (704403NCRC);  5432539, 00000339708HM0 (980212CT);  5432539, 00000341573HM4 (704993OPT540);  5432539, 00000379104HM3 (M69376CT540);  5432539, 00000386201HM8 (MWCT540);  5432539, Not Available (503DRCLCT);  5432539, 00000330505HM9 (972596CT540);  5432539, 00000362574HM6 (83103038250);  5432539-3, 00000401746HM3 (030091CT01);  5432539, 00000340246HM8 (M151671015);  5432539, 00000380389HM7 (M4162223);  5432539, 00000340244HM3 (A2032118);  5432539, 00000342043HM7 (M4166654);  5432539, 00000338323HM9 (F1680831);  5432539, 00000339266HM9 (M8322907);  5432539, 00000337351HM1 (M4168612);  5432539, 00000335057HM6 (B1303711);  5432539, 00000347508HM4 (D1929409);  5432539, 00000397400HM3 (X237371303);  5432539, 00000330901HM0 (M2001120);  5432539, 00000304669HM5 (M6044523);  5432539, 00000310044HM3 (M171587014);  5432539, 00000372848HM2 (M184220404);  5432539, 00000372847HM4 (M178185405);  5432539, 00000316797HM0 (M2397002);  5432539, 00000390005HM7 (M4475117);  5432539, 00000372104HM0 (M2485627);  5432539, 00000342971HM9 (A1570009);  5432539, 00000340695HM6 (M6013310);  5432539, 00000369110HM2 (M4500720);  5432539, 00000340247HM6 (A6039713);  5432539, 00000333921HM5 (M2862815);  5432539, 00000361672HM9 (M4481520);  5432539, 00000363482HM1 (M197296408);  5432539, 00000310043HM5 (P4200409);  5432539, 00000337349HM5 (L1650215);  5432539, 00000336112HM8 (X90281608);  5432539, 00000379351HM0 (M1265718);  5432539, 00000347407HM9 (M4549004);  5432539, 00000340697HM2 (X874019008);  5432539, 00000341571HM8 (M2399410);  5432539, 00000355434HM2 (M4490112);  5432539, 00000376542HM7 (X116370507);  5432539, 00000337350HM3 (A6036412);  5432539, 00000335056HM8 (M4190909);  5432539, 00000375285HM4 (M1354405);  5432539, 00000373337HM5 (M215252407);  5432539, 00000366019HM8 (M1245720);  5432539, 00000340696HM4 (M9185628);  5432539, 00000336113HM6 (X751962014);  5432539, 00000336740HM6 (M414408706);  5432539, 00000349635HM3 (X731650010);  5432539, 00000366654HM2 (M4008408);  5432539, 00000383020HM5 (M4491609);  5432539, 00000378190HM3 (M2621025);  5432539, 00000342970HM1 (M4202009);  5432539, 00000359798HM6 (M1377507);  5432539, 00000381695HM6 (M315152201);  5432539, 00000370244HM6 (M129645804);  5432539, 00000339707HM2 (M180384809);  5432539, 00000335749HM8 (B2397706);  5432539, 00000342042HM9 (M2311408);  5432539, 00000383018HM9 (M6083623);  5432539, 00000382245HM9 (P4192908);  5432539, 00000344616HM8 (O9885030);  5432539, 00000372421HM8 (O9885032);  5432539, 00000310045HM0 (M1118326);  5432539, 00000365596HM6 (M4497423);  5432539, 00000352680HM3 (M190773205);  5432539-3, 00000403028HM4 (X832010004);  5432539-3, 00000402466HM7 (X90281615);  5432539-3, 00000408382HM0 (X993729008);  5432539-3, 00000410589HM6 (M4433013);  5432539, 00000383016HM3 (GF1005CT02);  5432539, 00000322028HM2 (83021200033112);  5432539, 00000354311HM3 (83021825577213);  5432539, 00000318975HM0 (A5127815);  5432539, 00000339267HM7 (MQ1000CT03);  5432539, 00000395546HM5 (MA1020CT01);  5432539-3, 00000401722HM4 (85109807073);  5432539, 00000332407HM6 (PL2998CT01);  5432539, 00000356472HM1 (PL3198CT01);  5432539, 00000390578HM3 (PL1079CT01);  5432539, 00000359123HM7 (PL3595CT01);  5432539, 00000377066HM6 (PL1355CT03);  5432539-2, 00000049882YC4 (SA1095CT02);  5432539-2, 00000051253YC3 (SA2297CT01);  5432539, 00000352681HM1 (ZA2224CT02);  5432539, 00000317656HM7 (ZA1531CT01);  5432539, 00000327481HM8 (ZA1442CT03);  5432539, 00000342973HM5 (ZA1312CT03);  5432539, 00000334326HM6 (TN1624CT01);  5432539, 00000336739HM8 (TN1348CT01);  5432539, 00000328088HM0 (TN1087CT02);  5432539, 00000347969HM8 (BG4665CT01);  5432539, 00000368515HM3 (BG4034CT01);  5432539, 00000378191HM1 (CY1005CT02);  5432539, 00000379103HM5 (CY1006CT01);  5432539, 00000379102HM7 (CY1123CT01);  5432539, 00000380413HM5 (H2023CT03);  5432539, 00000373338HM3 (H2059CT08);  5432539, 00000386199HM4 (H2134CT05);  5432539, 00000367183HM1 (H2013CT01);  5432539, 00000405538HM0 (H2114CT03);  5432539, 00000394560HM7 (BG4605CT02);  5432539, 00000365597HM4 (HU1243CT02);  5432539, 00000369756HM2 (RO1265CT01);  5432539, 311096HM2 (317807CT540);  5432539, 00000304667HM9 (030079CT01);  5432539, 00000326872HM9 (030173CT04);  5432539, 00000310553HM3 (MP713117);  5432539, 00000347507HM6 (MPX18602);  5432539-3, 00000406037HM2 (RO1170CT02);  5432539-3, 00000406038HM0 (RO1089CT02);  5432539-3, CBAQG1600035HM (SA1058NM03);  5432539, 00000323060HM4 (850484MQCT);  5432539-2, 00000064092YC0 (617754OPT1);  5432539-2, 00000064530YC9 (EG1993CT01);  5432539-2, 00000070896YC6 (IR1534CT02);  5432539-2, 00000064093YC8 (EG1175CT02);  5432539-2, 00000061304YC2 (SA1091CT01);  5432539-2, 00000051472YC9 (SA1216CT01);  5432539-2, 00000050896YC0 (SA1264CT02);  5432539-2, 00000050257YC5 (SA1345CT01);  5432539-2, 00000049638YC0 (SA1014CT03);  5432539-2, 00000051160YC0 (SA2361CT01);  5432539-2, 00000051977YC7 (SA2326CT01);  5432539-2, 00000054177YC1 (SA1337CT01);  5432539-2, 00000049477YC3 (SA2296CT01);  5432539-2, 00000050719YC4 (SA2321CT01);  5432539-2, 00000050897YC8 (SA1138CT02);  5432539-2, 00000051161YC8 (SA2351CT01);  5432539-2, 00000054701YC8 (SA2211CT02);  5432539-2, 00000055091YC3 (SA1379CT02);  5432539-2, 00000056000YC3 (SA2387CT01);  5432539-2, 00000049640YC6 (SA2317CT01);  5432539-2, 00000049644YC8 (SA2319CT01);  5432539-2, 00000049641YC4 (SA1099CT02);  5432539-2, 00000063007YC9 (SA2419CT01);  5432539-2, 00000049881YC6 (SA2324CT01);  5432539-2, 00000049642YC2 (SA2320CT01);  5432539-2, 00000052281YC3 (SA1302CT02);  5432539-2, 00000063932YC8 (SA1105CT02);  5432539-2, 00000054702YC6 (SA1106CT01);  5432539-2, 00000049639YC8 (SA1117CT01);  5432539-2, 00000057164YC6 (SA1329CT01);  5432539-2, 00000057165YC3 (SA2397CT01);  5432539-2, 00000054357YC9 (SA2366CT01);  5432539-2, 00000049424YC5 (SA2316CT01);  5432539-2, 00000055092YC1 (SA1282CT02);  5432539-2, 00000049643YC0 (SA2322CT01);  5432539-2, 00000049646YC3 (SA2323CT01);  5432539-3, CBAQG1600024HM (DZ1947CT01);  5432539, 00000326873HM7 (83021822150013);  5432539, 00000349634HM6 (83021003960213);  5432539-3, CBAQG1600010HM (CBAQG1600010HM);  5432539-3, CBAQG1600027HM (DZ1930CT01);  5432539-3, CBAQG1600082HM (82421111115);  5432539-3, CBAQG1600083HM (82421111117);  5432539-3, CBAQG1600093HM (82421111128);  5432539-3, CBAQG1600066HM (82421120564);  5432539-3, CBAQG1600084HM (82421111120);  5432539-3, CBAQG1600102HM (82421111137);  5432539-3, CBAQG1600090HM (82421111126);  5432539, 00000425306HM8 (82421040373);  5432539, 00000399083HM5 (82421150153);  5432539-3, CBAQG1600081HM (82421160456);  5432539-3, CBAQG1600110HM (82421160463);  5432539, 00000391174HM0 (82421160388);  5432539, 00000406426HM7 (82421160397);  5432539, 00000427844HM6 (82421160420);  5432539, 00000379353HM6 (82421160374);  5432539-3, CBAQG1600129HM (82421160410);  5432539-3, CBAQG1600056HM (82421180156);  5432539-3, CBAQG1600055HM (82421240187);  5432539-3, CBAQG1600062HM (82421070439);  5432539, 00000386200HM0 (82421070400);  5432539, 00000399085HM0 (82421070402);  5432539, 00000430374HM9 (82421070431);  5432539, 00000373756HM6 (82421070375);  5432539, 00000379938HM4 (82421070386);  5432539, 00000382247HM5 (82421070383);  5432539-3, CBAQG1600095HM (82421010360);  5432539, 00000433312HM6 (82421010357);  5432539-3, CBAQG1700006HM (82421090596);  5432539-2, 00000073335YC2 (82421090555);  5432539-3, CBAQG1700009HM (82421090607);  5432539-3, CBAQG1700001HM (82421090605);  5432539, 00000388493HM9 (82421090517);  5432539-3, CBAQG1600076HM (82421210367);  5432539, 00000417307HM6 (82421190308);  5432539-3, CBAQG1600138HM (82421190375);  5432539, 00000409400HM9 (82421120491);  5432539, 00000416268HM1 (82421120503);  5432539, 00000418335HM6 (82421120512);  5432539, 00000381106HM4 (82421200251);  5432539, 00000398398HM8 (82421200254);  5432539, 00000383015HM5 (82421020199);  5432539-3, CBAQG1600050HM (82421020218);  5432539, 00000380412HM7 (82421030407);  5432539, 00000406427HM5 (82421060157);  5432539-3, CBAQG1700004HM (82421060178);  5432539, 00000390581HM7 (82421060152);  5432539, 00000415099HM1 (82421100803);  5432539-3, CBAQG1600124HM (82421100914);  5432539, 00000395547HM3 (82421130150);  5432539-3, CBAQG1600113HM (82421080167);  5432539, 00000419663HM0 (82421230368);  5432539, 00000417308HM4 (82421230358);  5432539-3, CBAQG1600100HM (82421230391);  5432539-3, CBAQG1600077HM (82421230399);  5432539, 00000414511HM6 (82421250171);  5432539, 00000393815HM6 (82421250164);  5432539, 00000382246HM7 (82421250158);  5432539, 00000427843HM8 (82421250179);  5432539-3, CBAQG1600088HM (82421140391);  5432539-3, CBAQG1600125HM (82421140404);  5432539, 00000390580HM9 (82421140319);  5432539-3, CBAQG1600131HM (82421140406);  5432539-3, CBAQG1600091HM (82421140393);  5432539-3, CBAQG1600094HM (82421140395);  5432539-3, CBAQG1600109HM (82421140397);  5432539-3, CBAQG1600134HM (82421140421);  5432539, 00000391173HM2 (82421140322);  5432539, 00000409401HM7 (82421140338);  5432539, 00000417309HM2 (82421140352);  5432539, 00000426002HM2 (82421140354);  5432539, 00000426433HM9 (82421140357);  5432539-3, CBAQG1600054HM (82421140377);  5432539-3, CBAQG1600057HM (82421140380);  5432539-3, CBAQG1600073HM (82421140382);  5432539-3, CBAQG1600087HM (82421140388);  5432539-3, CBAQG1700003HM (82421140425);  5432539, 00000391176HM5 (82421140326);  5432539, 00000415101HM5 (82421140346);  5432539, 00000426434HM7 (82421140360);  5432539, 00000427208HM4 (82421140361);  5432539-3, CBAQG1600133HM (82421140414);  5432539, 00000398399HM6 (82421140342);  5432539, 00000406428HM3 (82421140337);  5432539-3, CBAQG1600127HM (82421140417);  5432539, 00000435221HM7 (82421140366);  5432539, 00000399084HM3 (82421140333);  5432539-3, CBAQG1600120HM (82421140403);  5432539-3, CBAQG1700011HM (82421140434);  5432539-3, CBAQG1700016HM (82421140426);  5432539-3, CBAQG1600103HM (82421140398);  5432539, 00000435528HM5 (82421140371);  5432539, 00000391175HM7 (82421140330);  5432539-3, CBAQG1600085HM (82421140386);  5432539, 00000387455HM9 (82421140323);  5432539, 00000425105HM4 (82421140355);  5432539-3, CBAQG1600092HM (82421140392);  5432539-3, CBAQG1600119HM (82421140405);  5432539-3, CBAQG1600130HM (82421140418);  5432539-3, CBAQG1600132HM (82421140422);  5432539, 00000373757HM4 (82421140310);  5432539, 00000417310HM0 (82421140350);  5432539, 00000383017HM1 (82421140316);  5432539, 00000390577HM5 (82421140320);  5432539, 00000399853HM1 (82421140327);  5432539, 00000433732HM5 (82421140365);  5432539-3, CBAQG1600128HM (82421140420);  5432539, 00000360895HM7 (A5485256);  5432539-3, CBAQG1700008HM (DZ1031CT03);  5432539-3, CBAQG1600089HM (DZ2089CT01);  5432539-3, CBAQG1600108HM (DZ2090CT01);  5432539-3, CBAQG1600105HM (DZ1268CT02);  5432539-3, CBAQG1600121HM (DZ1856CT01);  5432539-3, CBAQG1500006HM (EG1069CT04);  5432539-3, 00000423305HM2 (M4161324);  5432539-3, CBAQG1600061HM (M6058821);  5432539-3, CBAQG1600072HM (X215527504);  5432539-3, CBAQG1600037HM (M2271513);  5432539-3, CBAQG1600136HM (X215528106);  5432539-3, CBAQG1600123HM (M4471610);  5432539-3, CBAQG1600098HM (M4498915);  5432539-3, 00000419688HM7 (M4172912);  5432539-3, CBAQG1600122HM (M4480511);  5432539-3, CBAQG1600111HM (M4486511);  5432539-3, CBAQG1500001HM (X189112207);  5432539-3, CBAQG1600080HM (M9957425);  5432539-3, CBAQG1600026HM (M4207319);  5432539-3, CBAQG1600030HM (X129757608);  5432539-3, CBAQG1600060HM (M2788816);  5432539-5, 540TA1600010YC (M2855814);  5432539-3, 00000423306HM0 (M4473007);  5432539-3, CBAQG1600048HM (M4503511);  5432539-3, CBAQG1700002HM (M470333901);  5432539-3, CBAQG1600063HM (X243995304);  5432539-3, CBAQG1600052HM (M9490524);  5432539-3, CBAQG1600071HM (M4494816);  5432539-3, CBAQG1600058HM (M4834011);  5432539-3, 00000414060HM4 (M408598101);  5432539-3, CBAQG1600017HM (M8317619);  5432539-3, CBAQG1600051HM (M461603402);  5432539-3, CBAQG1600075HM (M218772805);  5432539-3, CBAQG1600047HM (M6015636);  5432539-3, CBAQG1600137HM (PL3973CT01);  5432539, 00000356366HM5 (PC0075CT06);  5432539, 00000358082HM6 (HCX074CT06);  5432539, 00000383014HM8 (PG3383CT05);  5432539, 00000381696HM4 (HC7475CT04);  5432539, 00000394230HM7 (437739CT01);  5432539, 00000368953HM6 (PC1009CT01);  5432539, 00000366017HM2 (HC7669CT05);  5432539, 00000395548HM1 (HC1711CT02);  5432539, 00000380388HM9 (PPIR01CT04);  5432539, 00000379937HM6 (HC3076CT03);  5432539, 00000368514HM6 (PVIL01CT05);  5432539-3, 00000413603HM2 (CC1173CT02);  5432539-3, 00000413604HM0 (HPAD02CT04);  5432539, 00000318099HM9 (0824158CT01);  5432539, 00000318099HM9 (824158CT01);  5432539, 00000328882HM6 (00165CTS04);  6447929, 00000446468HM1 (RU2036CT01);  6447929, 00000447677HM6 (RU1670CT01);  6447929, 00000449980HM2 (RU8738CT01);  6447929, 00000453552HM2 (RU6164CT01);  6447929, 00000416256HM6 (RU5534CT01);  6447929, 00000416255HM8 (RU3468CT03);  6447929, 00000453541HM5 (RU9761CT01);  6447929, 00000453553HM0 (RU0024CT01);  6447929, 00000416254HM1 (RU9697CT01);  5432539-3, 411693HM5 (205655CT540);  5432539-3, CBAQG1600036HM (SHICT21);  5432539-3, CBAQG1600069HM (904450OMCT);  5432539-3, 403027HM6 (786596WKOPT);  5432539-3, 00000422256HM8 (INSIGHTCT1856);  5432539-3, 00000422258HM4 (229243CT);  5432539-3, CBAQG1500002HM (3011065);  5432539-3, 424069HM3 (3006500);  5432539-3, CBAQG1600006HM (3011112);  5432539-3, CBAQG1600014HM (3011063);  5432539-3, 422255HM0 (3006502);  5432539-3, CBAQG1500005HM (3006501);  5432539-3, CBAQG1600011HM (3011064);  5432539-3, CBAQG1500009HM (3006503);  5432539-3, CBAQG1600003HM (3011061);  5432539-3, CBAQG1700014HM (319283CT);  5432539-3, CBAQG1600015HM (712472540CT);  5432539-3, CBAQG1500004HM (620421CT540);  5432539-3, CBAQG1600004HM (859313OPD540);  5432539-3, 402467HM5 (318259LFMCT);  5432539-3, CBAQG1700018HM (318539OPT);  5432539-3, CBAQG1600039HM (RADNETCT1561);  5432539-3, CBAQG1600064HM (269245OPT);  5432539-3, 422257HM6 (651287OPT);  5432539-3, CBAQG1600009HM (507274CT540);  5432539-3, CBAQG1600045HM (417682540);  5432539-3, 402464HM2 (601268WCT540);  5432539-3, 413605HM7 (601936OPTCT);  5432539-3, 410591HM2 (732499OPT2);  5432539-3, 423307HM8 (702669CT);  5432539-3, 395472HM4 (914632CT540);  5432539-3, CBAQG1600068HM (614LCHCT16);  5432539-3, CBAQG1600043HM (864366OCT);  5432539-3, 424072HM7 (843347CT16);  5432539-3, CBAQG1600019HM (803637ECT);  5432539-3, CBAQG1600021HM (605874CT540);  5432539-3, 00000395471HM6 (605835CT540);  5432539-3, CBAQG1600001HM (605326CT540);  5432539-3, CBAQG1600046HM (423263CT540);  5432539-3, CBAQG1600033HM (325625CT2);  5432539-3, CBAQG1600041HM (936539OPCT);  5432539-3, CBAQG1600106HM (SHICT23);  5432539-3, CBAQG1600114HM (SHICT01426);  5432539-3, CBAQG1500010HM (903GKCT540);  5432539-3, CBAQG1600097HM (254PHCLLCT);  5432539-3, CBAQG1600031HM (806272CT540);  5432539-3, CBAQG1600101HM (SHICT01022);  5432539-3, CBAQG1700012HM (281MMSCT);  5432539-3, CBAQG1600044HM (804323CATH1);  5432539-3, CBAQG1600022HM (304369OPT);  5432539-3, 419687HM9 (INSIGHTCT1855);  5432539-3, CBAQG1600020HM (307578CT540);  5432539-3, CBAQG1700017HM (4424311CT11);  5432539-3, CBAQG1600070HM (418735OPTIMA);  5432539-5, 540TA1600011YC (419520OPT540);  5432539-5, 540TA1700003YC (423698OPT);  5432539-5, 540TA1600012YC (SHICT01428);  5432539-3, CBAQG1600059HM (396399CT04);  5432539-3, 00000418714HM2 (157504CT04);  5432539-3, CBAQG1600096HM (HC3295CT03);  5432539-3, CBAQG1600078HM (900765CT01);  5432539-3, 00000408381HM2 (PC3039CT01);  5432539-3, CBAQG1600032HM (HC0098CT03);  5432539-3, CBAQG1700005HM (DZ1396CT02 );  5432539-3, 00000410587HM0 (DZ1855CT01);  5432539-3, 00000419684HM6 (DZ1863CT01);  5432539-3, CBAQG1600099HM (83155337049);  5432539-3, CBAQG1600112HM (83155337009);  5432539-3, CBAQG1800009HM (082421070488);  5432539-3, CBAQG1800011HM (082421210415);  5432539-3, CBAQG1800007HM (082421290130);  5432539-3, 00000404920HM1 (HR4020CT02);  5432539-3, 00000403029HM2 (HR4103CT03);  5432539-3, 00000403030HM0 (HR4222CT01);  5432539-3, CBAQG1500003HM (ET1021CT01);  5432539-3, 00000422254HM3 (ET1033CT01);  5432539-3, CBAQG1600016HM (FI1158CT01);  5432539-3, CBAQG1500008HM (M4163513);  5432539-3, 00000412353HM5 (M2055807);  5432539-3, 00000412354HM3 (M4176612);  5432539-3, 00000410590HM4 (X185295804);  5432539-3, 00000410588HM8 (M2208511);  5432539-3, CBAQG1600023HM (M200598210);  5432539-3, 00000405601HM6 (X2266303);  5432539-3, 00000423304HM5 (M4398215);  5432539-3, 00000421080HM3 (HU1087CT02);  5432539-3, 00000424977HM7 (HU1093CT02);  5432539, 00000437610HM9 (83021609668716);  5432539-3, CBAQG1600028HM (IR1503CT02);  5432539-3, 00000421458HM1 (IR2110CT01);  5432539-3, CBAQG1600012HM (C5343407);  5432539-3, CBAQG1600007HM (A5128765);  5432539-3, 00000424070HM1 (C5128706);  5432539-3, CBAQG1600135HM (A5392204);  5432539-3, CBAQG1600065HM (A5188563);  5432539-3, CBAQG1600118HM (A5739707);  5432539-3, CBAQG1600034HM (LT4036CT02);  5432539-3, CBAQG1600115HM (1553CT0008);  5432539-3, CBAQG1600025HM (ML1009CT01);  5432539-3, CBAQG1600005HM (MA1184CT03);  5432539-3, 00000418715HM9 (MA1557CT02);  5432539-3, 00000412355HM0 (MA1054CT02);  5432539-3, CBAQG1700010HM (MA1420CT02);  5432539-3, CBAQG1600074HM (CBAQG1600074HM );  5432539-3, CBAQG1600107HM (PL3887CT01);  5432539-3, 00000421079HM5 (600135CT01);  5432539-3, CBAQG1600117HM (PL1613CT02);  5432539-3, CBAQG1600002HM (PL3594CT02);  5432539-3, 00000413435HM9 (RO1103CT02);  5432539-3, CBAQG1600038HM (RO1331CT01);  5432539-3, 00000418713HM4 (UA4311CT01);  5432539-3, 00000424071HM9 (CT424071HM9);  5432539-5, 00000074288YC2 (EG1017CT04);  5432539-5, 540TA1600002YC (EG2527CT01);  5432539-5, 540TA1700002YC (M463396701);  5432539-5, 540TA1600003YC (IR2168CT01);  5432539-5, 540TA1600005YC (IR2222CT01);  5432539-5, 540TA1600001YC (IR2096CT01);  5432539-5, 00000073893YC0 (PK1010CT02);  5432539-5, 00000072557YC2 (PA1110CT01);  5432539-5, 540TA1700001YC (5973CT0077);  
Recalling Firm/
Manufacturer		 GE Healthcare Japan Corporation
Ge Herusukea.Japan ( Kabu -4 Chome 7-127
Asahigaoka
Hino Japan
For Additional Information Contact
800-437-1171
Manufacturer Reason
for Recall		 GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.
FDA Determined
Cause 2		 Employee error
Action The firm, GE Healthcare, sent an " URGENT MEDICAL DEVICE CORRECTION" letter dated 4/27/2018 to its Customers on about 04/27/2018. The letter describes the product, problem and actions to be taken. The customers were Instructed to: download and provide the updated Service Manual to the organization that services the equipment on site and informed customers that GE Healthcare would be correcting all affected devices at no cost. Questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or the local Sales Representative. GE Healthcare expanded the recall to include an additional product and model number. Customers were notified on about 08/09/2018 via URGENT MEDICAL DEVICE CORRECTION letter. Instructions were the same as the original notification.
Quantity in Commerce 4,007 devices total (products 1, 2, 3)
Distribution Worldwide Distribution: US (Nationwide) distribution to states of: AK, AL, CA, CO, CT, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, RI, SC, SD, TN, TX, UT, WI, WV, WY; and countries of:: ALGERIA, ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CAMEROON, Canada, CHILE, CHINA, COLOMBIA, Cote D'Ivoire, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ETHIOPIA, FINLAND, FRANCE, French Guiana, GERMANY, GHANA, GREECE, GUADELOUPE, GUATEMALA, HONDURAS, Hong Kong, HUNGARY, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, Korea (Republic of), KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MALAYSIA, Mali, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW , ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, Palestine, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, REUNION, ROMANIA, Russia, RWANDA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA, VIETNAM, and YEMEN.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = GE MEDICAL SYSTEMS, LLC
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