Maestro 4000 (system of cardioablation)

2020: Boston Scientific warned about the rejected systems of cardioablation

At the beginning of February, 2020 the Boston Scientific company issued the express notice about security to warn about updating of a firmware for the system of radio-frequency cardioablation of Maestro 4000. Because of an error in software the device continues work even after switching off of the toggle-switch.

Earlier the producer notified clients on risk of inadvertent selection of the radio-frequency energy radiated by the Maestro 4000 device after switching off of the pedal switch. It was noted that even after switching off on a control panel radiation parameters continue to be displayed, and a system continues to publish the sound signal testimonial of operation of the device.

Boston Scientific issued the express notice about security to warn about updating of a firmware for the system of radio-frequency cardioablation of Maestro 4000

According to the notification on security of the device, this problem was observed only in systems using the optional foot switch. Affirmed as the instruction for application that at emergence of a similar situation it is necessary to press the control button a radio-frequency power supply on the system controller or the remote control.

Boston Scientific reported that regulatory bodies approved updating of a sikroprogramma for the solution of this problem, and the company began process of updating of a firmware of the Maestro 4000 systems. The company warned that updating removes only one potential cause of this deviation therefore the risk of resuming of problems owing to the unaccounted reasons still remains.

To users it is strongly recommended to permit representatives of Boston Scientific to update the Maestro 4000 systems on all objects in accordance with the established procedure according to the plan of maintenance. If the problem is not fixed, users should follow the instructions provided in the instruction and report without delay the accident and its effects to the local representative of Boston Scientific.^[1]

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