Recall Z-2097-2025— GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Name: FDA recall Z-2097-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-20

Class II · Ongoing

Class II FDA medical device recall by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING, initiated 2025-06-20. It names one FDA 510(k) clearance: K022960. Product: Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system. Reason: 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..

Recalling firm: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Classification: Class II
Status: Ongoing
Initiated: 2025-06-20
Firm location: Tirat Carmel, N/A, Israel

510(k) clearances named in this recall

1 on FDA's record

K022960 — GE QUASAR NUCLEAR MEDICINE SYSTEMGe Medical Systems F.I. Haifa·cleared 2002-09-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.