GE Healthcare, LLC: Medical Device Recall in 2018 - (Recall #: Z-0369-2019)

GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System

Class I

A detector can detach and fall.

System ID #: 0002910670AX, 0890013983, 0890079382, 0890079382, 201461MYO, 201858MYO, 202464MYO, 202741MYO, 203483MILL, 203688MYO, 203797NM13, 205739MC, 207641MYO, 209524MS, 209944MS, 212420MS, 212420MS1, 212535MS, 212777MS, 212870MS, 215624MYO, 215676MYO, 215707MYO1, 228523VAMS, 229386MYOS, 248937MYO, 252331MC2, 256341NRM2, 256549MYOS, 270465MYO, 270886MG, 276964MYO, 281313MYO1, 281477NM1, 301884MG, 301905MYO, 302322MG, 302733MYO, 303341MYO, 304256MYO, 304263MYO, 305446MC, 305512MC, 305538MC, 305666MC, 316261KCMC, 316858GMC9, 318574NM, 318728MG1, 318812MG2, 318927NM, 325574MG, 334793MYO1, 334793MYO2, 334821ACN, 337491MYO, 352333MG2, 352564MG, 401729MYO, 401829MYO, 402315MC, 402NHIMC, 405359EMY, 408795MY1, 414219MYO, 414ISCGACQ3, 416231MG2, 416465MYO, 416465XEL1, 416763MG, 417847MG, 423648MYO, 423778MG1, 435734MG, 440326MC3, 443481MYO, 478453NM, 478929MCV, 480279NM1, 480288MG, 480425NM2, 480505NM1, 480835NM1, 501202SMG, 501278MYO, 502226MG1, 02587MYO, 502893N5, 503535MGA, 504329MG, 505462MYO, 505662MYO, 505887NUC2, 508626MG, 508674MG, 508778MYO, 508828MYO, 508992GENIE, 509684MG, 509946KICACQ, 513585MYO, 515358WLMG, 516488MS1, 516520MG, 516599MS, 516627MS, 516775MS, 516789MS1, 516798ELCINT, 516798MS, 519428MYO, 530582MG1, 530674MCV, 541667MG, 561332MG, 561627MC, 570823MC1, 570969MYO, 573334MG1, 580250MG1, 585341MC1, 585442MYO, 585UCVAMC1, 586775MG, 601553MG, 601553MYO, 601982MYO1, 601982MYO2, 602239NM2, 602239NM3, 602978NM2, 605977MS, 605977MYO, 606330MYO, 607432FMC, 608348MG, 610776MG1, 610778MYO2, 614293MYO2, 614464MYO1, 614865MYO1, 615222STNM1, 615329MSN1, 615342CNM, 615342FCNM1, 615449MCV, 615791MSNM1, 615851STH1, 615868MSNM1, 619668MYOSIGHT, 623298NM1, 623815MYO1, 623936NM1, 626308MG, 631447MYOSIGHT, 650617MS, 650991MY1, 661321MYO, 705434MYO, 706722MC, 706733MYO, 713456NM1, 713779NM1, 713917MYO1, 713943HPNM1, 714870MYO, 716488MYO, 716674MYO, 716878MGNUC, 717217MYO, 717344MYO1, 717344MYO2, 718265MS, 718268MS, 718317MS, 718442MS, 718584MS, 718670MS, 718777MS, 718780MS, 718830MS, 718837MS, 718998MS, 724752MYO, 731635MG, 732249MG1, 732281MYO, 732287MYO, 732431MYO, 732660MYO, 732888MYO, 732923MC, 740653MYO1, 760957MG1, 770638MY, 770732MY, 781979MYO, 802524MG, 803256MY02, 803256MY03, 803771MY01, 812949MYO, 813353MYO, 813615MYO, 815759MYO, 816276BMYO, 817250MYO, 817481MS, 817543MG, 818243MC1, 818734MYO, 828586MYO, 843761MC, 847360MYO, 847444MYO, 850696WMG, 850912VAMY, 856374MYO, 856589MCV, 860350MILL, 863687MYO, 864455MYO, 864716MYO, 865984MYS, 870338MG, 870524MYO, 890013983, 890534MC, 904202MYO1, 904202MYO2, 907677NUCACQ, 908273MYO, 908587MYO, 913541OPM, 913684CMG, 914235MS, 914968MYO, 918307MY1, 919684MYST1, 920531MG, 928314NM1, 928505NM1, 928505NM2, 936266SLNM2, 940320MYO, 941412MYO, 941412MYO2, 941792MYO, 949770MYO, 954382MC1, 972475MYO, 972494MYO, 972562MY01, 972562MY02, 973267MYO, 973467MY2, 973543MYO, 973926MYO, 978462MYO, 985643MG, 985873MG2, 985875MG, 989723MYO, A5405211, BCTECH2184116, BCTECH8278, CCCMYO1, CVIMYO, FHGAMYO, FRIMG1, MHLORGENM1, MSSTL-TBD16, RADNETNM1735, RADNETNM1743, RADNETNM1746, and VASMYO

United States: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,Guam,MA,MD,ME,MI,MO,MS,MT,NC,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,PR, RI,SC,SD,TN,TX,UT,VA,VT,WA,WI AND WV International: Albania, Argentina, Australia, Azerbaijan, Belgium, Bosnia ,Herzegovina, Brazil, Canada, Chile, China, Costa Rica, Colombia, Cyprus, France, Germany, Greece, Guatemala, Honduras, Iceland, India, Iraq, Italy, Jamaica, Japan, Kenya, Korea, Macedonia, Mexico, Namibia, Panama, Peru, Philippines, Portugal, Russia, South Africa, Spain Switzerland, Taiwan, United Kingdom, Turkey, Venezuela and Vietnam

Voluntary: Firm initiated