Events

Recall of GE Varicam / VG

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69570
  • Event Risk Class
    Class 2
  • Event Number
    Z-0185-2015
  • Event Initiated Date
    2014-10-14
  • Event Date Posted
    2014-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130967
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, tomography, computed, emission - Product Code KPS
  • Reason
    Ge is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. ge is updating the preventative maintenance procedure and schedule, and added an additional preventative maintenance check for loose fasteners on the nuclear medicaine systems.
  • Action
    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter, GEHC Ref# 40860, dated October 14, 2014 to its consignees. The letter described the Safety Issue, safety Instructions, Affected Product Details, Product Correction, actions to be taken and Contact Information. For questions, consignees in the United States, can contact 1-800-437-1171, for other countries they can contact their GE Healthcare Service Representative.

Device

GE Varicam / VG
  • Model / Serial
    0000000010-203 203694MIL 0000000010-191 203852VG 10498 205933VH 10191 206288VG 10262 206598VG 10571 207795VH 10269 208529VG 1078 209334LNVG1 10340 209526milvg 10541 212562VG 1081 225763MVG 000003100-1829 228818MILLVG 00008125-18-18 248338MLO02 10237 248828VG 10326 248937VG 1538 256235OPNM1 10171 262785vg 1039 2894872VG2 1080 2894872VG3 10316 301896VG 10177 304256VG 00000000010-15 304487VG 10156 305612VG 10197 309662SJVG 10539 310231VGH1 10395 312864VG 1058 313299VG 00000000010-63 334794MILVG 1372 361575VG 000000099-4-04 402449SJVG 10189 404605PVGH 1107 407277fvg2 1132 407896FVG1 10211 407933KVG 10438 408947VG 10199 409291HVG 10460 410955VG1 10359 410955VH 10406 412359VG 00000000010-31 413781VG1 00000000010-82 413781VG2 10547 414219VG 10375 414328VG 10534 414384vg 10182 414447VG 3874990 414544VG 5007 414777MIL 10139 414777VG2 10555 414961vg 1141 443643VG 10347 480981NM1 10354 508997VG 10338 510486VG1 1056 512753VG 10481 515263LVG 1035 516256VG 10210 520757NM1 10572 530529VG 10281 540596N3 10190 540953VG 10179 559688NM1 10150 570791HAWK 10193 580355VGACQ 00008125-16-70 58510 00008125-16-89 58582 00008125-18-09 58711 00008125-18-16 58919 00000000017-64 58958 1016 601426VG 10300 602870NM1 10501 605333HAWKEYE 10284 608263VG 10446 608364VG 1119 609267VG 10146 610954VG 1100 615322NM2 10178 615791VG 10041 630801VG 10280 706845VG 10267 707554VG 00000011278NU9 708783VG 3003 714774VG 1126 716694VG 10235 716859VG 1013 718759VG 10263 781278VG 10526 781744VG2 10488 781744VH 10507 804281VG1 00000000010-05 812537VG 10165 813725vg 36478041 813788VG 10307 815842SJVG 10239 828213VG 10398 845437VG 1025 847695MILMVG 10459 847842VG 10143 860343VGOPC 00000000010-30 860344VG 10390 863494VG 10260 904202VG 10435 914734VG 10422 920459VG 10309 920887vg 10445 949760vg1 10222 956632MVG 000003681-1803 970491VG1 1075 978466VG 10357 978741VG 10218 979764VGH1 10409 FHORLVGH1 1046 MAYO4VG3 10491 NM73049 10353 NM81394 10180 RADNETNM1724 10530 509575PYVGH 00000000010-54 203932VG 00000000018-24 59012 5004 912633MCVG 000003100-1840 919684VG1 00000000010-50 MAYO1VG4 10256 MAYO1VGH1 1113 973754VG 00008125-38-18 58993 10288 912764VG 10569 NM10569 10291 NM10291 10174 NM10174 10473 910265011 10028 AH0101NM02 10392 AH0101NM03 10129 AH3701NM04 10302 AH4307NM04 10576 AH4660NM05 10518 110012NU02 10224 110965NU05 10590 160070NU01 DUMFMI40849016 190226NU17 10475 030082NU10 00000000010-45 030355NU02 00000000017-27 030010NU02 10493 220166NU01 00000000017-15 030151NU05 00000000016-17 030388NU01 10339 080041NU01 10172 030028nu01 10568 030220NU02 1111 92635 1034 79722 10367 12865 343 0343A 000003100-1763 0360A 10166 38070 61061 61061 00000000010-04 63422 10173 66515 0000D4360X4372 6970 00000000030-11 73240-1 10374 NM10374 10378 NM10378 1649 0112B 10377 84636 1021 56948 1019 75074 00000000010-67 0277A 1074 99691 1042 79966 10040 204837HK1 1289 416284VG 0000000010-134 416284VG2 10175 416290VG 10164 416444VG 10384 416469DVH 1010 416534VG2 1072 416586VG 10146 416656vg 10133 416747VG 10449 416756VG 10283 450359VG1 10295 450359VG2 10410 514495VG 10169 613548VG 10276 613548VG2 1066 705324VG 00000000017-10 705327VARICAM 10209 705652VG 10376 807343BMILLVG 10381 807343CMILLVG 10244 819563CVG 1756 819822VG 10420 905527HAWKEYE 10332 905683VG 10216 905845VG 10454 905846VG 000003100-1719 905848VG 10124 905855VG 10158 905883VG 10396 82426160016 10606 82426180003 10287 82426010009 10514 82426010010 10522 82426010011 10176 82426030009 10268 82426030010 10206 82426030016 10564 82426030018 10328 82426040020 10264 82426040021 10456 82426040024 10486 82426040026 10489 82426040029 10342 82426050001 10562 82426050002 10589 82426050003 10520 82426070016 10368 82426090013 10424 82426100019 10434 82426100020 10448 82426100023 10240 82426140007 10402 82426140009 10487 82426140011 10249 82426160014 10403 82426160017 10428 82426160019 10531 82426160022 10313 82426190008 10397 82426190010 10598 82426200002 10574 82426230010 10450 82426250002 10591 82426280001 10483 82426290004 1155 82426310005 10303 82426100017 10519 82426040025 10550 82426070015 10439 82426080006 10363 82426080007 10599 82426080009 10548 82426110002 10314 82426120003 10297 82426120004 10401 82426130012 10250 82426130015 10401 82426130019 10121 82426140005 10400 82426140008 10540 82426140012 000003100-1743 82426150003 10207 82426150006 10194 82426160012 10476 82426160020 10584 82426160023 10204 82426210003 10595 82426210010 10594 82426220006 000003100-1760 NM3100-1760 10360 CY1088MN04 00000000017-47 CS1341NM01 DUMFMI40849019 DK1026NM05 00000000010196 EE1020MN01 10196 EE4020MN01 10345 M2846904 1144 M5400305 1086 A2846901 10559 M4024091 10527 M4134620 10243 M4144845 10558 M4143939 10325 M4160707 00000000016-71 540186NU01 DUMFMI40849010 580505NU01 10282 CC0618NU13 10229 HC2250NU01 10254 HC2250NU02 10251 HC2250NU03 10485 HC3314NU01 10168 HC4387NU01 10457 HJJT01NU02 10355 HT2106NU05 DUMFMI40849009 PC0173NU06 00000000010-59 PC0396NU03 1076 PC2306NU01 10505 PC4178NU01 10431 UC1129NU01 10495 UC1769NU07 10458 UC4092NU01 10600 UC4109NU01 10253 HBER01NU02 10320 HT2106NU02 00000000018-22 418404NU01 10319 HC5036NU01 10587 H2094NUC07 10582 H2103NUC06 UNKASM00109200 H1404NUC06 10212 83026242548139 10508 83026031062021 10188 8302603135243 10364 8302621006334 10294 83026862100513 10279 8302606123002 1814 IL1020NM01 10312 IL1028NM13 00000000018-23 IL1059NM01 00000000016-73 IL1061NM01 10167 IL1061NM05 00000000030-04 IL1062NM01 UNKASM00109204 IL1066NM03 40772394 IL1072NM01 00000000018-39 A5103321 1704 A5107736 1085 A5111021 1729 A5114718 00000ICPO50612 A5116033 1153 A5128734 10399 A5132115 1697 A5177338 1696 A5177340 1095 A5177344 1149 A5177347 1105 A5215912 1145 A5236208 000000163-1758 A5306504 10230 A5333009 10552 A5632411 10265 A5647407 10416 B5119109 10575 B5131812 10521 B5164103 10185 B5315325 DUMFMI40849014 C5123638 10567 A5353816 10480 B5365411 1693 A5188524 10433 B5152905 1003 YN0440 00000000030-14 YN0444 00000000030-15 YN0448 1002 YN0450 1006 YN0455 1038 YN0468 1027 YN0475 00000000010-37 YN0477 00000000010-44 YN0479 10032 YN0482 10057 YN0486 00000000010-55 YN0493 1091 YN0498 1060 YN0502 1073 YN0506 1099 YN0542 1102 YN0543 1106 YN0544 10180 YN0639 10187 YN0640 10217 YN0641 10236 YN0642 1116 YN0643 10234 YN0844 10242 YN0845 10292 YN0847 10238 YN0848 10305 YN0849 10241 YN0851 10336 YN0852 10336 YN0853 10389 YN0854 10373 YN0907 10467 YN0909 10217 YN0910 10504 YN0912 10544 YN0913 10525 YN0915 10593 YN0917 10586 YN0918 10542 YN0919 10447 YN0920 10601 YN0921 10565 YN0922 10603 YN0923 10597 YN0924 10563 YN0966 10408 YN0978 10386 YN0979 10436 YN0980 10479 YN0981 10477 YN0982 1112 YN0983 10543 YN0984 10545 YN0985 10538 YN0986 10596 YN0988 10537 YN1000 00000000030-16 YN0454 1835 850260033 1118 850260034 1831 850260035 10362 850260038 10387 850260040 10393 850260041 10366 850260042 10466 850260046 10510 850260048 10579 850260054 10585 850260057 10605 850260062 1804 0850EL0012 1069 223410MILVG 10385 589907mvg 1101 ALK0130 10371 APL0236 10474 DHG0536 10023 DLF0237 10512 NO1015MN03 10388 NO1016MN27 1687 NM0382E00013 00000000017-20 600062NM01 00000000017-22 PL1008NM01 00000000017-23 PL1003NM01 10352 PER10924 10346 PER10925 10529 PMR12503 10515 PER02544 1617 1617 1061 NM1061-MVG 00008125-16-25 NM8125-16-25 10115 10115 000003100-1838 NM3100-1838 000008125-1630 NM8125-1630 1008 NM1008-MVG 10103 787782VARICAM-1 10414 RU1100NM01 10561 RU1591NM01 10553 RU1457NM01 10461 RU1704NM01 10494 SK1071NM01 DUMFMI40849005 SK1082NM01 10417 DE282013 10334 DE619831 DUMFMI40849011 DEL26415 10323 EEF51528 10425 FE416038 10270 FE816127 10426 FEB52048 1101 GEC21815 10453 GEE34020 10343 ME260802 10348 ME612431 10533 MPX24714 10412 YE645816 10405 YE645817 10382 ME504345 10468 A004NU10 10560 E001NU09 10463 G001NU07 1890 U001NU12 10581 853940082 1065 853940069 1998 853940077 1999 853940078 00000000016-86 856260014 00000000017-31 856260019 10195 16003NUC03 00000000017-36 06007NUC16 000003100-1744 UK1135NM01 10333 00584NUC01 00000000018-40 00222NUC01 00000000010-01 00023NUC06 10516 00243NUC11 10551 00243NUC15 10556 00243NUC17 10379 00269NUC07 UNKASM00109201 00357NUC02 00000000010-64 70050NUC06 10462 10433nuc01 10557 00216NUC09 000003101-1502 20091001VG
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including Guam, Puerto Rico and DC; and countries of: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELRARUS, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, GREECE, GUADELOUPE, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA,MARTINIQUE, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN,SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, UKRAINE, URUGUAY, VENEZUELA, VIET NAAM.
  • Product Description
    GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508PA, H2508PB, H2508PC, H2508PD. || Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA