FDA recall Z-1820-2025
GE Medical Systems, LLC · Class II · device
Product
OEC 3D
Reason for recall
OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
Distribution
US and OUS
Key facts
- Status
- Ongoing
- Initiation date
- 2025-03-21
- Report date
- 2025-06-18
- Voluntary/Mandated
- FDA Mandated
- Location
- Waukesha, WI, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1820-2025