Company: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Date of Enforcement Report: 7/8/2025
Class: II
PRODUCT
Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
Recall Number:
Z-2097-2025
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/MANUFACTURER:
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
VOLUME:
1822
DISTRIBUTION:
Worldwide – US Nationwide distribution.
