GE Healthcare Varicam/VG and VG Hawkeye devices Product recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

System ID: 2998, 6970, 12865, 21414, 38070, 53263, 55461, 56948, 58230, 58378, 58379, 58483, 58510, 58582, 58622, 58630, 58711, 58785, 58797, 58808, 58810, 58871, 58883, 58919, 58958, 58993, 59012, 61061, 63422, 66515, 75074, 79722, 79966, 84636, 92635, 99691, 0850260033, 0850260034, 0850260035, 0850260038, 0850260040, 0850260041, 0850260042, 0850260046, 0850260048, 0850260054, 0850260057, 0850260062, 0853940029, 0853940068, 0853940069, 0853940077, 0853940078, 0853940080, 0853940082, 0856260014, 0856260019, 0910265011, 0910453006, 082426010009, 082426010010, 082426010011, 082426020002, 082426030009, 082426030010, 082426030015, 082426030016, 082426030018, 082426040016, 082426040020, 082426040021, 082426040024, 082426040025, 082426040026, 082426040029, 082426050001, 082426050002, 082426050003, 082426070014, 082426070015, 082426070016, 082426080006, 082426080007, 082426080009, 082426090013, 082426100017, 082426100019, 082426100020, 082426100023, 082426110002, 082426120003, 082426120004, 082426130012, 082426130013, 082426130014, 082426130015, 082426130016, 082426130019, 082426140005, 082426140007, 082426140008, 082426140009, 082426140011, 082426140012, 082426150003, 082426150006, 082426160012, 082426160014, 082426160016, 082426160017, 082426160019, 082426160020, 082426160022, 082426160023, 082426180003, 082426190008, 082426190010, 082426200002, 082426210002, 082426210003, 082426210010, 082426220006, 082426230008, 082426230010, 082426250002, 082426280001, 082426290004, 082426310005, 082426310007, 082426310008, 08302603017002, 08302603135243, 08302606123002, 08302621006334, 083026031062021, 083026242100654, 083026590040004, 083026590040010, 083026598000594, 083026826753913, 0382E00013, 00023NUC06, 0009D, 00132NUC02, 00216NUC09, 00243NUC11, 00243NUC15, 00243NUC17, 00269NUC07, 00323NUC02, 00357NUC02, 00555NUC01, 00584NUC01, 00584NUC04, 0112B, 0277A, 030010NU02, 030028NU01, 030036NU06, 030082NU10, 030151NU05, 030220NU02, 030355NU02, 030388NU01, 0306A, 0343A, 0360A, 06007NUC16, 080041NU01, 082426040029P, 082426050001P, 082426140005P, 0850EL0011, 0850EL0012, 10433NUC01, 110012NU02, 110965NU05, 130083NU07, 13228MILLEN, 16003NUC03, 160070NU01, 190226NU17, 190282NU04, 203694MIL, 203852VG, 203932VG, 204837VG, 205823NMVG, 205933VH, 206288VG, 206598VG, 207795VH, 208529VG, 209334LNVG1, 209526MILVG, 212562VG, 215893VG, 220166NU01, 223410MILVG, 225763MVG, 228818MILLVG, 248828H, 248828VG, 248937VG, 256235OPNM1, 262785VG, 2894872VG2, 2894872VG3, 301896VG, 304256VG, 304487VG, 309662SJVG, 310231VGH1, 310289VG1, 312864VG, 313299VG, 334794MILVG, 361575VG, 402449SJVG, 404605PVGH, 404712VG, 406782SNM, 407277FVG2, 407896FVG1, 407933KVG, 408947VG, 409291HVG, 410605NM1, 410955VG1, 410955VH, 412359VG, 413781VG1, 413781VG2, 414219VG, 414328VG, 414384VG, 414447VG, 414544HEYE, 414544VG, 414777MIL, 414777VG2, 414961VG, 416284VG, 416284VG2, 416290VG, 416444VG, 416469DVH, 416534VG1, 416534VG2, 416586VG, 416656VG, 416747VARICAM, 416747VG, 416756VG, 418404NU01, 418862VARICAM, 419383VG, 440329VG, 443643VG, 450359VG1, 450359VG2, 480981NM1, 501686VG, 508997VG, 509575PYVGH, 510486VG1, 512753VG, 514495VG, 515263LVG, 516256VG, 518271SVG, 519421VG, 520757NM1, 530529VG, 540186NU01, 540596N3, 540953VG, 541276AVG, 559688NM1, 570791HAWK, 580355VGACQ, 589907MVG, 600062NM01, 601426VG, 602406VG, 602870NM1, 605333HAWKEYE, 608263VG, 608364VG, 609267VG, 610954VG, 613548VG, 613548VG2, 615322NM2, 615791VG, 630801VG, 70050NUC06, 705324VG, 705327VARICAM, 705743VG, 706845VG, 707554VG, 708422MIL, 708783VG, 714774VG, 715361VG, 716694VG, 716859VG, 717657VG, 718759VG, 718780GENIEVG, 718780VG, 73240-1, 781278VG, 781744VG2, 781744VH, 786090NU03, 787782VARICAM-1, 804281VG1, 807343BMILLVG, 807343CMILLVG, 809758VARICAM, 812537VG, 813725VG, 813788VG, 815842SJVG, 819563CVG, 819822VG, 828212VG, 828213VG, 843792NUCH, 845437VG, 847695MILMVG, 847842VG, 860343VGOPC, 860344VG, 863494VG, 864573MBVG1, 904202VG, 905472VG, 905527HAWKEYE, 905683VG, 905684VG, 905684VG2, 905845VG, 905848VG, 905855VG, 905883VG, 905895VG, 912691SCVG, 914734VG, 919684VG1, 920459VG, 920729VG, 920887VG, 949760VG1, 956632MVG, 956687HKI, 970491VG1, 973754VG, 978466VG, 978741VG, 979764VGH1, 989269VG, A004NU10, A2846901, A5103321, A5107736, A5111021, A5114718, A5116033, A5128734, A5129932, A5132115, A5177338, A5177340, A5177344, A5177347, A5188524, A5215912, A5236208, A5306504, A5333009, A5353816, A5632411, AH0101NM02, AH0101NM03, AH3701NM04, AH4307NM04, AH4660NM05, ALK0130, ALK0131, APL0236, B4155407, B5119109, B5131812, B5315325, B5365411, B5483426, C5123638, CC0618NU13, CY1088MN04, D007NU07, DE282013, DE619831, DEL26415, DHG0536, DK1026NM05, DLF0237, E001NU09, EE1020MN01, EEF51528, FE416038, FE816127, FEB52048, FHALTVGH1, FHORLVGH1, G001NU07, GEC21815, GEE34020, H1404NUC06, H2103NUC06, H5174NUC02, HBER01NU02, HC2250NU01, HC2250NU02, HC2250NU03, HC3314NU01, HC4387NU01, HC5036NU01, HJJT01NU02, HOR0250, HR4106NM01, HT2106NU02, HT2106NU05, ID9320, IL1020NM01, IL1028NM03, IL1028NM13, IL1059NM01, IL1061NM01, IL1061NM05, IL1062NM01, IL1066NM03, IL1067NM03, IL1072NM01, JHOCVG10464, M001NU10, M001NU14, M2846904, M2881704, M4024091, M4134620, M4143939, M4144609, M4144845, M4145121, M4160707, M4164912, M4211044, M5400305, M5460632, MAYO1VG4, MAYO1VGH1, MAYO4VG3, MC6946NU02, ME260802, ME504345, ME612431, MPX24714, NM10374, NM73049, NM73050, NM81394, NO1012MN04, NO1015MN03, NO1016MN27, PC0173NU06, PC0396NU03, PC2306NU01, PC4178NU01, PER02544, PER10924, PER10925, PL1003NM01, PL1008NM01, PL1143NM01, PMR12503, PPR12206, RADNETNM1724, RU1100NM01, RU1457NM01, RU1591NM01, SK1071NM01, SK1082NM01, U001NU12, UC1129NU01, UC1769NU07, UC4092NU01, UC4109NU01, WH231NM1, YE645816, YE645817, YN0438, YN0440, YN0444, YN0448, YN0450, YN0454, YN0455, YN0468, YN0475, YN0477, YN0479, YN0482, YN0486, YN0493, YN0498, YN0502, YN0506, YN0542, YN0543, YN0544, YN0638, YN0639, YN0640, YN0641, YN0642, YN0643, YN0844, YN0845, YN0846, YN0847, YN0848, YN0849, YN0850, YN0851, YN0852, YN0853, YN0854, YN0907, YN0909, YN0910, YN0911, YN0912, YN0913, YN0914, YN0915, YN0917, YN0918, YN0919, YN0920, YN0921, YN0922, YN0923, YN0924, YN0966, YN0979, YN0980, YN0981, YN0982, YN0983, YN0984, YN0985, YN0986, YN0987, YN0988, YN1000, YN1009, ZA1807NM08, ZWL0431,

Product

GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging…

Recalling firm

GE Healthcare, LLC

Quantity

571

Distribution

Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.

Recall date

July 31, 2013

Classification

Class I

Status

Terminated

Agency

FDA (device)