FDA-Device2025-10-29Class IIPROCESSING DEFECT
Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac 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.
Who it affects
Adults
Illnesses reported
None reported
Sold states
Worldwide
Affected count
11 units
Manufactured in
9, Andrey Sakharov, Haifa, Israel
Products
Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0290-2026Don't want to check this manually?
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