Z-0369-2019Class I

GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System

Name: Z-0369-2019 GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System
Creator: GE Healthcare, LLC
Published: 2018-09-14
License: https://open.fda.gov/license/

GE Healthcare / initiated 2018-09-14 / Terminated

FDA source

GE Healthcare, LLC began a recall of GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System on 2018-09-14. FDA classified it as Class I and gives the reason as "A detector can detach and fall". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0369-2019
Classification: Class I
Status: Terminated
Initiated: 2018-09-14
Posted: 2018-11-14
Terminated: 2020-10-08
Recalling firm: GE Healthcare
Product: GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: A detector can detach and fall.
FDA root cause: Other
Action: GE Healthcare will inspect and if required correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the inspection.
Quantity in commerce: 276
Distribution: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0369-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0369-2019	Class I	Terminated	Voluntary: Firm initiated	2018-11-21	2018-11-13
Z-0370-2019	Class I	Terminated	Voluntary: Firm initiated	2018-11-21	2018-11-13
Z-0371-2019	Class I	Terminated	Voluntary: Firm initiated	2018-11-21	2018-11-13

Product code KPS

K962738Class IIMillennium Mt and Millennium Mg Nuclear Medicine SystemsGE Medical Systems / cleared 1996-10-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)