GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and vascular ...
FDA Device Recall #Z-2872-2018 — Class II — April 27, 2018
Recall Summary
| Recall Number | Z-2872-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 27, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Healthcare Japan Corporation |
| Location | Hino |
| Product Type | Devices |
| Quantity | 4,007 devices total (products 1, 2, 3) |
Product 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 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.
Distribution Pattern
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 / 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);
Other Recalls from GE Healthcare Japan Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2873-2018 | Class II | GE Healthcare Optima CT660. The systems are in... | Apr 27, 2018 |
| Z-2871-2018 | Class II | GE Healthcare Optima CT660. Sold under the fol... | Apr 27, 2018 |
| Z-2870-2018 | Class II | GE Healthcare Revolution EVO, Optima CT660, Opt... | Apr 27, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.