FDA recall Z-2097-2025

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · Class II · device

Product

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

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.

Key facts

Status: Ongoing
Initiation date: 2025-06-20
Report date: 2025-07-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tirat Carmel, N/A, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2097-2025