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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted embolization), additional procedure/treatment required, blockage other than target vessel, increased procedure time, incomplete embolization, and/or inability to treat the patient.
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Ultrasound transducer devices were refurbished beyond their useful life.
Ultrasound transducer devices were refurbished beyond their useful life.
Ultrasound transducer devices were refurbished beyond their useful life.
Ultrasound transducer devices were refurbished beyond their useful life.
Ultrasound transducer devices were refurbished beyond their useful life.
Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
Ultrasound transducer devices were refurbished beyond their useful life.
Ultrasound transducer devices were refurbished beyond their useful life.
Ultrasound transducer devices were refurbished beyond their useful life.
Ultrasound transducer devices were refurbished beyond their useful life.
Ultrasound transducer devices were refurbished beyond their useful life.
Ultrasound transducer devices were refurbished beyond their useful life.
Ultrasound transducer devices were refurbished beyond their useful life.
Ultrasound transducer devices were refurbished beyond their useful life.
Ultrasound transducer devices were refurbished beyond their useful life.