BEUDAMED
    FDA Enforcement Class II Terminated

    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

    Recall: Z-2872-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2872-2018
    Event ID
    80563
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare Japan Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 29, 2018
    Initiation Date
    April 27, 2018
    Classification Date
    August 17, 2018
    Termination Date
    August 21, 2020
    Address
    Ge Herusukea.Japan ( Kabu -4 Chome 7-127, Asahigaoka, Hino, N/A, Japan

    Description

    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

    Reason

    GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.

    Code Info

    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);

    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.

    Quantity

    4,007 devices total (products 1, 2, 3)