Calendar

Week of Sep 8, 2025

Sep 12, 2025device recall352d agoArgon Medical Devices, Inc device recall (Cls II)

Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: " Pulmonary thromboembolism when anticoagulants are contraindicated " Failure of anticoagulant therapy in thromboembolic disease " Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced " Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated — Reason: Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied — Status: Ongoing

full page →fda device recalls ↗

Sep 12, 2025device recall352d agoGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING device recall (Cls II)

Millenium MG/MC; 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 recall352d agoDiagnostica Stago, Inc. device recall (Cls II)

Product: STA Liatest D-Di; REF: 00515; — Reason: A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots. — Status: Ongoing

full page →fda device recalls ↗

Sep 12, 2025device recall352d 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 recall352d 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 recall352d 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 recall352d 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 recall352d 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 recall352d 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 recall352d 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 recall352d 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 recall352d 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 recall352d 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 recall352d 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 recall352d 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 recall352d 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 recall352d 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 recall352d 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, 2025grant352d 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