Urgent Recall – SmartDrive SpeedControl Dial - NO COST Replacement & Safety Check

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The purpose of this letter is to inform you of a recall, following consultation with the Therapeutic Goods Administration (TGA), involving the SpeedControl Dial component utilised with the SmartDrive MX2+ Power Assist Device manufactured between August 2023 through November 2024. 

Reason for the Recall:

The SpeedControl Dial is a wired control option for the SmartDrive power assist device. Through market feedback and subsequent investigation, Permobil has identified a material change with the printed circuit board assembly (PCBA) in the SpeedControl Dial resulting in inconsistent performance problems. The following are scenarios that some users may experience:

• Continued drive: The SpeedControl Dial does not fully stop the drive unit when rotated to zero position.

• Involuntary movement: Unintended activation of the SmartDrive motor without intentional user input while the SpeedControl Dial is at zero position and dial light is flashing in stand-by-mode.

• Loss of power to SpeedControl Dial: When the dial is rotated forward from zero position, SmartDrive motor movement is initiated, and then the SpeedControl Dial unexpectedly shuts down.

• Failure to start driving: When the dial is rotated forward from zero position, no SmartDrive motor activation occurs.

Risk to Health:

If an individual is using an impacted SpeedControl Dial, they may experience one of the above performance problems. This could result in the SmartDrive motor continuing to run, unexpectedly initiating movement, or stopping unexpectedly. Depending on the scenario, this could lead to serious injury.

Possible actions for each performance problem include:

• Continued drive: Press the face of the SpeedControl Dial. This is an alternative stop

option to disengage power assist.

• Involuntary movement: Press the face of the SpeedControl Dial. This is an

alternative stop option to disengage power assist.

• Loss of power to SpeedControl Dial: Rotate the SpeedControl Dial back to the

zero position and reengage power assist.

• Another potential action to the above problems is to swap the switch on the rear of

the dial from ”R” (right) to “L” (left). While this results in the controls of the dial

performing opposite of what it does when set to “R”, this has been shown to address

performance problems in some scenarios.