GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system

Recall date

June 20, 2025

Source

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

Recall number

Z-2097-2025

FDA classification

Class II

Brand / firm

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Sold / distributed

Worldwide - US Nationwide distribution.

Why it was recalled

Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening 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

Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system