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SmartDrive Speed Control Dial Recalled Due To Unresponsive Motor

RTTNews | 233 days ago

(RTTNews) - Advanced medical technology firm Max Mobility/Permobil, part of Patricia Industries, a unit of Sweden's Investor AB, has recalled the Speed Control Dial component used with the SmartDrive MX2+ Power Assist Device, citing the potential safety and performance concerns.

The frame-mounted Max Mobility / Permobil Brand - MX2-3DCK/MX2-3DC - Speed Control is easily mounted to a wheelchair to allow for close access and easy pressing. The U.S. Food and Drug Administration noted that the Speed Control Dial can be used to deactivate the SmartDrive motor, as well as provide a means of actively powering the motor.

The recall was initiated after receiving 646 complaints associated with the Speed Control Dial as of December 12, 2024. In these, three serious injuries have been reported, including a fractured hip, fractured tibia, and fractured malleolus bone.

The impacted products were manufactured and distributed through authorized dealers between August 17, 2023, and November 21, 2024.

A material change with the printed circuit board assembly in the Speed Control Dial was identified by Max Mobility/Permobil. The material change can cause performance issues such as continued drive, involuntary movement, loss of power, and failure to start driving.

Due to the material change, the Speed Control Dial does not fully stop the drive unit when rotated to the zero position, and there could be unintended activation of the SmartDrive motor without intentional user input while the Speed Control Dial is at the zero position and the dial light is flashing in standby mode.

In addition, when the Speed Control Dial is rotated forward from the zero position, SmartDrive motor movement is initiated, and then the Speed Control Dial unexpectedly shuts down. The agency also noted that when the dial is rotated forward from the zero position, no SmartDrive motor activation occurs.

An individual, if using an impacted Max Mobility/Permobil Speed Control Dial, may experience any of these issues. Due to these, the SmartDrive motor may continue to run, unexpectedly initiating movement, or stopping unexpectedly.

Depending on the scenario, users may experience minor injuries such as skin irritation, minor cuts, and bruises, and/or serious injuries such as a muscle or ligament strain or tear, bone fracture in an extremity, and/or concussion.

In addition, for individuals standing or sitting in close proximity to the end user, unintentional activation and/or inability to turn off power assist could cause serious injury such as a bone fracture in an extremity.

The purchasers of the impacted Speed Control Dial model numbers are asked to request replacement Speed Control Dial units.

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