FDA-Device2025-10-29Class II
Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Hazard
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Sold states
Worldwide
Affected count
64 units
Manufactured in
9, Andrey Sakharov, Haifa, Israel
Products
Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0291-2026Don't want to check this manually?
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