GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recall records

40 reported ongoing

41 records in this archive. Latest source date Dec 24, 2025.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

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 L...

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...

Class IIReported completed

Distribution: Worldwide distribution. US Nationwide, Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, El Salvador, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, ...

Official source for GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI L...
FDA device enforcement

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 reloca...

Class IIReported ongoing

Distribution: US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece

Official source for SMV DSX New Line, System, Tomography, Computed, Emission
FDA device enforcement

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 reloca...

Class IIReported ongoing

Distribution: US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece

Official source for SMV DSI, System, Tomography, Computed, Emission
FDA device enforcement

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 reloca...

Class IIReported ongoing

Distribution: US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece

Official source for SMV BodyTrack, System, Tomography, Computed, Emission
FDA device enforcement

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 reloca...

Class IIReported ongoing

Distribution: US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece

Official source for MAXXUS, System, Tomography, Computed, Emission
FDA device enforcement

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 ...

Class IIReported ongoing

Distribution: Worldwide

Official source for Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA device enforcement

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 ...

Class IIReported ongoing

Distribution: Worldwide

Official source for Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA device enforcement

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 ...

Class IIReported ongoing

Distribution: Worldwide

Official source for Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA device enforcement

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 ...

Class IIReported ongoing

Distribution: Worldwide

Official source for Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA device enforcement

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 ...

Class IIReported ongoing

Distribution: Worldwide

Official source for Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA device enforcement

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 ...

Class IIReported ongoing

Distribution: Worldwide

Official source for Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA device enforcement

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 ...

Class IIReported ongoing

Distribution: Worldwide

Official source for Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA device enforcement

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 ...

Class IIReported ongoing

Distribution: Worldwide

Official source for Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA device enforcement

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 ...

Class IIReported ongoing

Distribution: Worldwide

Official source for Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac ima...
FDA device enforcement

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 ...

Class IIReported ongoing

Distribution: Worldwide

Official source for Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA device enforcement

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 ...

Class IIReported ongoing

Distribution: Worldwide

Official source for Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA device enforcement

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 ...

Class IIReported ongoing

Distribution: Worldwide

Official source for Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA device enforcement

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 ...

Class IIReported ongoing

Distribution: Worldwide

Official source for Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera d...
FDA device enforcement

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 ...

Class IIReported ongoing

Distribution: Worldwide

Official source for Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA device enforcement

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 IIReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source for Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system

Reasons in these listed records

  • 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 f...
  • 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...
  • 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,...
  • 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.

These examples come from this result page and are not a ranking of every recall reason.

Checking GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Is there a recall on ge medical systems israel, functional imaging right now?

This archive contains 41 records, including 40 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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