Z-0369-2019 Class I Terminated
FDA device recall Z-0369-2019 was initiated by GE Healthcare, LLC on Sep 14, 2018 and is designated Class I. Reason for recall: A detector can detach and fall. The recall status is terminated (terminated Oct 8, 2020). Affected quantity: 276.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 21, 2018
- Initiation Date
- Sep 14, 2018
- Termination Date
- Oct 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 276
Product Description
GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System
Reason for Recall
A detector can detach and fall.
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
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0369-2019
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026