GE Healthcare Japan Corporation: 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 number

Z-2872-2018

Recalling firm

GE Healthcare Japan Corporation

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

Status

Terminated

Initiated

2018-04-27

Posted

not on file

Terminated

2020-08-21

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.

Root cause

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

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.

Lot, serial or model codes

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);

510(k) numbers

["K082816"]

PMA numbers

not on file

Product code

JAK

Firm FEI

3002808529

Firm city

Hino

Firm state

Asahigaoka

Firm country

Japan

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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