GE Medical Systems Israel, Functional Imaging
Haifa, IL
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING appears in FDA device records in Haifa, IL. FDA records list 4 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 41 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for GE Medical Systems Israel, Functional Imaging between 2010 and 2025. The busiest year on record is 2025, with 2. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2024 | 1 |
| 2025 | 2 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3027338963 | 3027338963 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | Andrei Sakharov St 9, Haifa 3508415 IL | 2026 | |
| 9613299 | 3004571294 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | 4 HAYOZMA ST., TIRAT HACARMEL Haifa 30200 IL | 2026 | |
| 3033524251 | 3033524251 | GE Medical Systems Israel, Functional Imaging | Ha Peles 18, Haifa 26289 IL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
Showing 25 of 41| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1112-2026 | GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission | 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 streaking artifact is most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation). | Class II | Open, Classified | |
| Z-1047-2026 | MAXXUS, System, Tomography, Computed, Emission | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems. | Class II | Open, Classified | |
| Z-1046-2026 | SMV BodyTrack, System, Tomography, Computed, Emission | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems. | Class II | Open, Classified | |
| Z-1045-2026 | SMV DSI, System, Tomography, Computed, Emission | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems. | Class II | Open, Classified | |
| Z-1044-2026 | SMV DSX New Line, System, Tomography, Computed, Emission | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems. | Class II | Open, Classified | |
| Z-0303-2026 | Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | Class II | Open, Classified | |
| Z-0302-2026 | Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | Class II | Open, Classified | |
| Z-0301-2026 | Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | Class II | Open, Classified | |
| Z-0300-2026 | Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | Class II | Open, Classified | |
| Z-0299-2026 | Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | Class II | Open, Classified | |
| Z-0298-2026 | Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | Class II | Open, Classified | |
| Z-0297-2026 | Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | Class II | Open, Classified | |
| Z-0296-2026 | Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | Class II | Open, Classified | |
| Z-0295-2026 | Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | Class II | Open, Classified | |
| Z-0294-2026 | Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | Class II | Open, Classified | |
| Z-0293-2026 | Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | Class II | Open, Classified | |
| Z-0292-2026 | Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | Class II | Open, Classified | |
| Z-0291-2026 | Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | Class II | Open, Classified | |
| Z-0290-2026 | Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | Class II | Open, Classified | |
| Z-2098-2025 | Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System | 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. | Class II | Open, Classified | |
| Z-2097-2025 | Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system | 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. | Class II | Open, Classified | |
| Z-0900-2025 | GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) ASM001092; 3) SYS000001; System, Tomography, Computed, Emission | 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 Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | Class II | Open, Classified | |
| Z-0899-2025 | GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5) H3000WC; 6) H3000WD; 7) H3000WT; 8) H3000WW; 9) H3000WY; 10) H3000WZ; System, Tomography, Computed, Emission | 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 Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | Class II | Open, Classified | |
| Z-0898-2025 | GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000YS; System, Tomography, Computed, Emission | 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 Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | Class II | Open, Classified | |
| Z-0897-2025 | GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission | 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 Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain