FDA-Device2025-07-16Class II
Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Hazard
Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.
Sold states
Worldwide - US Nationwide distribution.
Affected count
21
Manufactured in
4, Hayozma St, N/A, Tirat Carmel, N/A, Israel
Products
Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2098-2025Don't want to check this manually?
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