510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-2872-2018Class II

GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and vascular X-ray...

GE Healthcare Japan Corporation / initiated 2018-04-27 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

GE Healthcare Japan Corporation began a recall of GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.Sold under the following... on . FDA classified it as Class II and gives the reason as "GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2872-2018
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
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
Product code
JAK System, X-Ray, Tomography, Computed
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.
Root cause tag
manufacturing process
FDA 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 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.
Product codes and lots
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);

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2872-2018
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2870-2018Class IITerminatedVoluntary: Firm initiated
Z-2871-2018Class IITerminatedVoluntary: Firm initiated
Z-2872-2018Class IITerminatedVoluntary: Firm initiated
Z-2873-2018Class IITerminatedVoluntary: Firm initiated