Day

July 8, 2025
08
Jul

FDA Recall: Unintended detector motion may result in life-threatening injury

July 8, 2025
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....
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