Device product
GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System
Z-0369-2019
Product summary
- Event
- Event 81339
- Status
- Terminated
- Classification
- Class I
- Quantity
- 276
- Official record key
device-enforcement:Z-0369-2019
Official wording
Reason: A detector can detach and fall.
Code information: 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
Distribution pattern: 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
Derived failure modes
-
Unknown
A detector can detach and fall.