GE Healthcare Millennium MC
FDA device recall Z-0371-2019 · posted 2018-11-14 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- A detector can detach and fall.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 18
- 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, Arge
- Date initiated
- 2018-09-14
- Date posted
- 2018-11-14
- Date terminated
- 2020-10-08
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS (K962738) | GE Medical Systems | 1996-10-10 |