Recall Z-0370-2019 ยท KPS System, Tomography, Computed, Emission
GE Healthcare, LLC
GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System
| Date | Nov 14, 2018 (initiated Sep 14, 2018) |
| Status | Terminated |
| Reason | A detector can detach and fall. |
| 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 | 1,166 |
| 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 Ric |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962738 | MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS GE Medical Systems, Oct 10, 1996 |