FDA-Device2025-07-16Class II
Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 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
1822
Manufactured in
4, Hayozma St, N/A, Tirat Carmel, N/A, Israel
Products
Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2097-2025Don't want to check this manually?
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