Recall archive
7 recalls · page 1 of 1
Reported Jan 28, 2026
GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Medical Systems Israel, Functional Imaging
Matched: Brand · Product · Product details · Reason for recall — There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This…
FDA (openFDA device enforcement)
Reported Jan 21, 2026
SMV DSX New Line, System, Tomography, Computed, Emission
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Medical Systems Israel, Functional Imaging
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 29, 2025
Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Medical Systems Israel, Functional Imaging
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or…
13 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 16, 2025
Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Medical Systems Israel, Functional Imaging
Matched: Brand · Product · Product details · 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Medical Systems Israel, Functional Imaging
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear…
12 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 19, 2024
MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Medical Systems Israel, Functional Imaging
Matched: Brand · Product · Product details — There is a potential issue regarding the service handles for the internal lead (Pb) covers in that the handles could loosen or release which could…
FDA (openFDA device enforcement)
Reported Feb 15, 2023
GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA, c)…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Ge Medical Systems Israel, Functional Imaging
Matched: Brand · Product · Product details — A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
5 more products in this recall
FDA (openFDA device enforcement)
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