Recall

ge medical systems israel, functional imaging

21 recalls on record

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — 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 Le

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).

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — 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.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — 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.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — 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.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — 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.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — 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.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — 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.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — 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.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — 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.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — 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.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — 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.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — 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.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — 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.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — 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.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — 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.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — 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.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — 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.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — 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.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — 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.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — 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.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — 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.