GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls SMV DSX New Line, System, Tomography, Computed, Emission

Recall date

December 10, 2025

Source

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

Recall number

Z-1044-2026

FDA classification

Class II

Brand / firm

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Sold / distributed

US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece

Why it was recalled

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) 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. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.

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

What was recalled

SMV DSX New Line, System, Tomography, Computed, Emission