FDA-Device2025-06-18Class II
OEC 3D
GE Medical Systems, LLC
Hazard
OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
Sold states
US and OUS
Affected count
Total for both products: 3472 (2,919 US; 553 OUS)
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
OEC 3D
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1820-2025Don't want to check this manually?
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