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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING: 41 FDA recall reports
Every medical device recall the FDA has published for GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING. The fault, and how the agency graded it.
41Reports
6Class I
41Ongoing
2026-01-28Most recent
6 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32,
Z-1112-2026 · Class II · reported 2026-01-28 · Ongoing
- Why it was recalled
- 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).
- Product
- 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
- Where it went
- Worldwide distribution. US Nationwide, Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, El Salvador, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Korea (Republic Of), Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Poland, Romania, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkiye, United Kingdom, and Uzbekistan.
- How much
- 364 units
SMV DSI, System, Tomography, Computed, Emission
Z-1045-2026 · Class II · reported 2026-01-21 · Ongoing
- Why it was recalled
- 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.
- Product
- SMV DSI, System, Tomography, Computed, Emission
- Where it went
- US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece
- How much
- 3 units
SMV BodyTrack, System, Tomography, Computed, Emission
Z-1046-2026 · Class II · reported 2026-01-21 · Ongoing
- Why it was recalled
- 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.
- Product
- SMV BodyTrack, System, Tomography, Computed, Emission
- Where it went
- US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece
- How much
- 12 units
SMV DSX New Line, System, Tomography, Computed, Emission
Z-1044-2026 · Class II · reported 2026-01-21 · Ongoing
- Why it was recalled
- 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.
- Product
- SMV DSX New Line, System, Tomography, Computed, Emission
- Where it went
- US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece
- How much
- 7 units
MAXXUS, System, Tomography, Computed, Emission
Z-1047-2026 · Class II · reported 2026-01-21 · Ongoing
- Why it was recalled
- 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.
- Product
- MAXXUS, System, Tomography, Computed, Emission
- Where it went
- US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece
- How much
- 38 units
Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Z-0293-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- 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.
- Product
- Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Where it went
- Worldwide
- How much
- 28 units
Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Z-0299-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- 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.
- Product
- Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Where it went
- Worldwide
- How much
- 292 units
Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Z-0291-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- 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.
- Product
- Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Where it went
- Worldwide
- How much
- 64 units
Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Z-0297-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- 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.
- Product
- Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Where it went
- Worldwide
- How much
- 1386 units
Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Z-0298-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- 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.
- Product
- Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Where it went
- Worldwide
- How much
- 82 units
Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Z-0303-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- 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.
- Product
- Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Where it went
- Worldwide
- How much
- 102 units
Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Z-0295-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- 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.
- Product
- Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Where it went
- Worldwide
- How much
- 3 units
Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed speci
Z-0302-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- 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.
- Product
- Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Where it went
- Worldwide
- How much
- 205 units
Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Z-0292-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- 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.
- Product
- Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Where it went
- Worldwide
- How much
- 45 units
Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Z-0294-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- 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.
- Product
- Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Where it went
- Worldwide
- How much
- 15 units
Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Z-0300-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- 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.
- Product
- Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Where it went
- Worldwide
- How much
- 54 units
Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Z-0290-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- 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.
- Product
- Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Where it went
- Worldwide
- How much
- 11 units
Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Z-0296-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- 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.
- Product
- Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Where it went
- Worldwide
- How much
- 37 units
Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Z-0301-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- 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.
- Product
- Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Where it went
- Worldwide
- How much
- 1 unit
Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
Z-2097-2025 · Class II · reported 2025-07-16 · Ongoing
- Why it was recalled
- 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.
- Product
- Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 1822
Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
Z-2098-2025 · Class II · reported 2025-07-16 · Ongoing
- Why it was recalled
- 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.
- Product
- Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 21
GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomog
Z-0889-2025 · Class II · reported 2025-01-22 · Ongoing
- Why it was recalled
- 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.
- Product
- GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Computed, Emission
- Where it went
- Worldwide
- How much
- 116 units
GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; Syste
Z-0888-2025 · Class II · reported 2025-01-22 · Ongoing
- Why it was recalled
- 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.
- Product
- GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Emission
- Where it went
- Worldwide
- How much
- 36 units
GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emi
Z-0895-2025 · Class II · reported 2025-01-22 · Ongoing
- Why it was recalled
- 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.
- Product
- GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission
- Where it went
- Worldwide
- How much
- 8 units
GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN
Z-0892-2025 · Class II · reported 2025-01-22 · Ongoing
- Why it was recalled
- 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.
- Product
- GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H3100BT; 5) H3100PX; System, Tomography, Computed, Emission
- Where it went
- Worldwide
- How much
- 76 units
GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emi
Z-0894-2025 · Class II · reported 2025-01-22 · Ongoing
- Why it was recalled
- 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.
- Product
- GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission
- Where it went
- Worldwide
- How much
- 17 units
GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE,
Z-0891-2025 · Class II · reported 2025-01-22 · Ongoing
- Why it was recalled
- 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.
- Product
- GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CG, 5) H3100AG, 6) H3100JW, 7) H3100NC; System, Tomography, Computed, Emission
- Where it went
- Worldwide
- How much
- 859 units
GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000YS; System, T
Z-0898-2025 · Class II · reported 2025-01-22 · Ongoing
- Why it was recalled
- 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.
- Product
- GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000YS; System, Tomography, Computed, Emission
- Where it went
- Worldwide
- How much
- 93 units
GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Em
Z-0897-2025 · Class II · reported 2025-01-22 · Ongoing
- Why it was recalled
- 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.
- Product
- GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission
- Where it went
- Worldwide
- How much
- 877 units
GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission
Z-0896-2025 · Class II · reported 2025-01-22 · Ongoing
- Why it was recalled
- 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.
- Product
- GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission
- Where it went
- Worldwide
- How much
- 430 units
Showing the 30 most recent of 41. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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