Class II

Medical Device Recall: Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · June 20, 2025

Reason for Recall

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.

Distribution

Worldwide - US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

1822

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2097-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Medical Device Recall: Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system | SafeCheck