Loading...
Loading...
Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
There is a potential software error during programming.
Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing the button of the footswitch it might occur that the movement does not stop when releasing the button, result in potential risk to the patient's eye
Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts at a rate substantially higher than pump in the overall population.
Complaint trend regarding needle shaft gas leaks.
Complaint trend regarding needle shaft gas leaks.
Complaint trend regarding needle shaft gas leaks.
Complaint trend regarding needle shaft gas leaks.
Complaint trend regarding needle shaft gas leaks.
Complaint trend regarding needle shaft gas leaks.
Complaint trend regarding needle shaft gas leaks.
Complaint trend regarding needle shaft gas leaks.
The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
Complaint trend regarding needle shaft gas leaks.
Complaint trend regarding needle shaft gas leaks.
Complaint trend regarding needle shaft gas leaks.
Complaint trend regarding needle shaft gas leaks.
Complaint trend regarding needle shaft gas leaks.
Complaint trend regarding needle shaft gas leaks.
Complaint trend regarding needle shaft gas leaks.