GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically f…

Recall date

September 12, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0302-2026

FDA classification

Class II

Brand / firm

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Sold / distributed

Worldwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging