Ge Medical Systems Israel, Functional Imaging

Complete recall history across all FDA and CPSC categories — 41 total recalls

Ge Medical Systems Israel, Functional Imaging appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (41)

FDA medical device enforcement actions by Ge Medical Systems Israel, Functional Imaging

Date Product Reason Class
Dec 24, 2025 GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16,... There is a potential intermittent issue on certain Omni Legend systems that c... Class II
Dec 10, 2025 MAXXUS, System, Tomography, Computed, Emission GE HealthCare has become aware that certain Nuclear Medicine systems that are... Class II
Dec 10, 2025 SMV DSX New Line, System, Tomography, Computed, Emission GE HealthCare has become aware that certain Nuclear Medicine systems that are... Class II
Dec 10, 2025 SMV BodyTrack, System, Tomography, Computed, Emission GE HealthCare has become aware that certain Nuclear Medicine systems that are... Class II
Dec 10, 2025 SMV DSI, System, Tomography, Computed, Emission GE HealthCare has become aware that certain Nuclear Medicine systems that are... Class II
Sep 12, 2025 Optima NX; dual-head nuclear medicine gamma camera designed specifically for ... GE HealthCare has become aware that certain Nuclear Medicine systems that are... Class II
Sep 12, 2025 Maxicam; dual-head nuclear medicine gamma camera designed specifically for ca... GE HealthCare has become aware that certain Nuclear Medicine systems that are... Class II
Sep 12, 2025 Elscint Cardial; dual-head nuclear medicine gamma camera designed specificall... GE HealthCare has become aware that certain Nuclear Medicine systems that are... Class II
Sep 12, 2025 Millenium MPS; dual-head nuclear medicine gamma camera designed specifically ... GE HealthCare has become aware that certain Nuclear Medicine systems that are... Class II
Sep 12, 2025 Elscint Varicam; dual-head nuclear medicine gamma camera designed specificall... GE HealthCare has become aware that certain Nuclear Medicine systems that are... Class II
Sep 12, 2025 Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically f... GE HealthCare has become aware that certain Nuclear Medicine systems that are... Class II
Sep 12, 2025 Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear med... GE HealthCare has become aware that certain Nuclear Medicine systems that are... Class II
Sep 12, 2025 Elscint Helix; dual-head nuclear medicine gamma camera designed specifically ... GE HealthCare has become aware that certain Nuclear Medicine systems that are... Class II
Sep 12, 2025 Starcam/Camstar; dual-head nuclear medicine gamma camera designed specificall... GE HealthCare has become aware that certain Nuclear Medicine systems that are... Class II
Sep 12, 2025 Millenium Myosight; dual-head nuclear medicine gamma camera designed specific... GE HealthCare has become aware that certain Nuclear Medicine systems that are... Class II
Sep 12, 2025 Millenium MG/MC; dual-head nuclear medicine gamma camera designed specificall... GE HealthCare has become aware that certain Nuclear Medicine systems that are... Class II
Sep 12, 2025 Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifica... GE HealthCare has become aware that certain Nuclear Medicine systems that are... Class II
Sep 12, 2025 Millenium MPR; dual-head nuclear medicine gamma camera designed specifically ... GE HealthCare has become aware that certain Nuclear Medicine systems that are... Class II
Sep 12, 2025 Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically f... GE HealthCare has become aware that certain Nuclear Medicine systems that are... Class II
Jun 20, 2025 Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine ... Unintended radial detector motion may occur during patient setup or during pa... Class II
Jun 20, 2025 Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine s... Unintended radial detector motion may occur during patient setup or during pa... Class II
Dec 18, 2024 GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM ... Class II
Dec 18, 2024 GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-7... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM ... Class II
Dec 18, 2024 GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, ... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM ... Class II
Dec 18, 2024 GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM ... Class II
Dec 18, 2024 GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System,... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM ... Class II
Dec 18, 2024 GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT;... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM ... Class II
Dec 18, 2024 GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2)... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM ... Class II
Dec 18, 2024 GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM ... Class II
Dec 18, 2024 GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; ... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM ... Class II
Dec 18, 2024 GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM ... Class II
Dec 18, 2024 GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; ... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM ... Class II
Dec 18, 2024 GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, ... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM ... Class II
Dec 18, 2024 GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H24... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM ... Class II
Apr 15, 2024 MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H39... There is a potential issue regarding the service handles for the internal lea... Class II
Dec 19, 2022 GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 D... A mitigation may not be correctly implemented. If this is the case, the detec... Class I
Dec 19, 2022 GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3... A mitigation may not be correctly implemented. If this is the case, the detec... Class I
Dec 19, 2022 GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / D... A mitigation may not be correctly implemented. If this is the case, the detec... Class I
Dec 19, 2022 GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ G... A mitigation may not be correctly implemented. If this is the case, the detec... Class I
Dec 19, 2022 GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 /... A mitigation may not be correctly implemented. If this is the case, the detec... Class I
Dec 19, 2022 GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8... A mitigation may not be correctly implemented. If this is the case, the detec... Class I

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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