Calendar

Week of Sep 8, 2025

Sep 12, 2025device recall337d agoGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING device recall (Cls II)

Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging — Reason: 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. — Status: Ongoing

full page →fda device recalls ↗

Sep 12, 2025device recall337d agoGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING device recall (Cls II)

Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging — Reason: 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. — Status: Ongoing

full page →fda device recalls ↗

Sep 12, 2025device recall337d agoGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING device recall (Cls II)

Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging — Reason: 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. — Status: Ongoing

full page →fda device recalls ↗

Sep 12, 2025device recall337d agoGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING device recall (Cls II)

Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging — Reason: 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. — Status: Ongoing

full page →fda device recalls ↗

Sep 12, 2025device recall337d agoGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING device recall (Cls II)

Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging — Reason: 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. — Status: Ongoing

full page →fda device recalls ↗

Sep 12, 2025device recall337d agoGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING device recall (Cls II)

Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging — Reason: 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. — Status: Ongoing

full page →fda device recalls ↗

Sep 12, 2025device recall337d agoGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING device recall (Cls II)

Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging — Reason: 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. — Status: Ongoing

full page →fda device recalls ↗

Sep 12, 2025device recall337d agoUIH Technologies LLC device recall (Cls II)

Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only — Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. — Status: Ongoing

full page →fda device recalls ↗

Sep 12, 2025device recall337d agoUIH Technologies LLC device recall (Cls II)

Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only — Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. — Status: Ongoing

full page →fda device recalls ↗

Sep 12, 2025device recall337d agoGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING device recall (Cls II)

Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging — Reason: 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. — Status: Ongoing

full page →fda device recalls ↗

Sep 12, 2025device recall337d agoUIH Technologies LLC device recall (Cls II)

Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only — Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. — Status: Ongoing

full page →fda device recalls ↗

Sep 12, 2025device recall337d agoGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING device recall (Cls II)

Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging — Reason: 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. — Status: Ongoing

full page →fda device recalls ↗

Sep 12, 2025device recall337d agoUIH Technologies LLC device recall (Cls II)

Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx Only — Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. — Status: Ongoing

full page →fda device recalls ↗

Sep 12, 2025device recall337d agoPhilips North America device recall (Cls II)

Cardiac Workstation 7000; Model Number: 860441; — Reason: Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short. — Status: Ongoing

full page →fda device recalls ↗

Sep 12, 2025device recall337d agoGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING device recall (Cls II)

Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging — Reason: 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. — Status: Ongoing

full page →fda device recalls ↗

Sep 12, 2025grant337d agoUNIVERSITY OF MIAMI CORAL GABLES — Remotely-Delivered Cognitive Behavioral Stress Management Effects on Cancer-A...

CA grant. $2,746,080. PI: MICHAEL Howard ANTONI

Week of Sep 8, 2025