FDA-Device2025-10-29Class IIPROCESSING DEFECT

Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

OTHERNationwide distributionMedical devices
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.

Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide
Affected count
102 units
Manufactured in
9, Andrey Sakharov, Haifa, Israel
Products
Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0303-2026

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