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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis of hematological malignancy, delayed treatment, and the need for additional patient samples.
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
Machining error on cams renders the device unusable.
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic.
There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
Potential component failure in the Gradient Coil could product smoke and/or fire.
Potential component failure in the Gradient Coil could product smoke and/or fire.
A small percentage of devices in three lots of product may contain a tape with a natural rubber latex adhesive which is not declared on the label
Potential component failure in the Gradient Coil could product smoke and/or fire.
Potential component failure in the Gradient Coil could product smoke and/or fire.
Potential component failure in the Gradient Coil could product smoke and/or fire.
Potential component failure in the Gradient Coil could product smoke and/or fire.
Potential component failure in the Gradient Coil could product smoke and/or fire.
Undeclared latex