FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: GE Healthcare Millennium MC
- Recall number
- Z-0371-2019
- Recalling firm
- GE Healthcare, LLC
- Product
- GE Healthcare Millennium MC
- Status
- Terminated
- Initiated
- 2018-09-14
- Posted
- 2018-11-14
- Terminated
- 2020-10-08
- 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
- 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, 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
- Lot, serial or model codes
- System ID #: 870735MG, 928333WMM02, 970635MYO, 203576DNT, 407896FMG2, 954634MG, 316267KCN, 601883NMC2, 910483XEL1, 910296MMG, 908277XL2, 908277MG2, 908218MYO, 918496EN1, 972759CROWNMG, 940566MG, 972434MC,and 972473MYO.
- 510(k) numbers
- ["K962738"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28