| 2025-12-24 |
Class II
|
Ongoing |
Z-1112-2026 |
GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legen… |
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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 … |
| 2025-12-10 |
Class II
|
Ongoing |
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 … |
| 2025-12-10 |
Class II
|
Ongoing |
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 … |
| 2025-12-10 |
Class II
|
Ongoing |
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 … |
| 2025-12-10 |
Class II
|
Ongoing |
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 … |
| 2025-09-12 |
Class II
|
Ongoing |
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 withou… |
| 2025-09-12 |
Class II
|
Ongoing |
Z-0302-2026 |
Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically fo… |
— |
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated withou… |
| 2025-09-12 |
Class II
|
Ongoing |
Z-0301-2026 |
Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging |
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GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated withou… |
| 2025-09-12 |
Class II
|
Ongoing |
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 withou… |
| 2025-09-12 |
Class II
|
Ongoing |
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 withou… |
| 2025-09-12 |
Class II
|
Ongoing |
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 withou… |
| 2025-09-12 |
Class II
|
Ongoing |
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 withou… |
| 2025-09-12 |
Class II
|
Ongoing |
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 withou… |
| 2025-09-12 |
Class II
|
Ongoing |
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 withou… |
| 2025-09-12 |
Class II
|
Ongoing |
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 withou… |
| 2025-09-12 |
Class II
|
Ongoing |
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 withou… |
| 2025-09-12 |
Class II
|
Ongoing |
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 withou… |
| 2025-09-12 |
Class II
|
Ongoing |
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 withou… |
| 2025-09-12 |
Class II
|
Ongoing |
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 withou… |
| 2025-06-20 |
Class II
|
Ongoing |
Z-2098-2025 |
Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System |
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Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Un… |
| 2025-06-20 |
Class II
|
Ongoing |
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. Un… |
| 2024-12-18 |
Class II
|
Ongoing |
Z-0900-2025 |
GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) ASM001092; 3) SYS000001… |
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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 s… |
| 2024-12-18 |
Class II
|
Ongoing |
Z-0899-2025 |
GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5)… |
— |
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 s… |
| 2024-12-18 |
Class II
|
Ongoing |
Z-0898-2025 |
GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000YS; System, Tomography,… |
— |
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 s… |
| 2024-12-18 |
Class II
|
Ongoing |
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 s… |
| 2024-12-18 |
Class II
|
Ongoing |
Z-0896-2025 |
GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; 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 s… |
| 2024-12-18 |
Class II
|
Ongoing |
Z-0895-2025 |
GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; 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 s… |
| 2024-12-18 |
Class II
|
Ongoing |
Z-0894-2025 |
GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; 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 s… |
| 2024-12-18 |
Class II
|
Ongoing |
Z-0893-2025 |
GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3… |
— |
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 s… |
| 2024-12-18 |
Class II
|
Ongoing |
Z-0892-2025 |
GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H31… |
— |
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 s… |
| 2024-12-18 |
Class II
|
Ongoing |
Z-0891-2025 |
GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401C… |
— |
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 s… |
| 2024-12-18 |
Class II
|
Ongoing |
Z-0890-2025 |
GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5… |
— |
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 s… |
| 2024-12-18 |
Class II
|
Ongoing |
Z-0889-2025 |
GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Com… |
— |
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 s… |
| 2024-12-18 |
Class II
|
Ongoing |
Z-0888-2025 |
GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomogra… |
— |
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 s… |
| 2024-04-15 |
Class II
|
Ongoing |
Z-2040-2024 |
MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (… |
— |
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 cause a cover… |
| 2022-12-19 |
Class I
|
Ongoing |
Z-1058-2023 |
GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 86… |
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A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury. |
| 2022-12-19 |
Class I
|
Ongoing |
Z-1057-2023 |
GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, … |
— |
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury. |
| 2022-12-19 |
Class I
|
Ongoing |
Z-1056-2023 |
GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, … |
— |
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury. |
| 2022-12-19 |
Class I
|
Ongoing |
Z-1055-2023 |
GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, … |
— |
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury. |
| 2022-12-19 |
Class I
|
Ongoing |
Z-1054-2023 |
GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20,… |
— |
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury. |
| 2022-12-19 |
Class I
|
Ongoing |
Z-1053-2023 |
GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA, … |
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A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury. |