Max Mobility/Permobil, an advanced medical technology firm and a part of Patricia Industries under Sweden's Investor AB, has announced a recall of the Speed Control Dial component used in the SmartDrive MX2+ Power Assist Device. This recall is due to identified safety and performance issues.
The affected Max Mobility/Permobil Speed Control — model numbers MX2-3DCK/MX2-3DC — is designed for easy mounting on wheelchairs to facilitate user accessibility. The U.S. Food and Drug Administration highlighted that the Speed Control Dial is capable of deactivating the SmartDrive motor and enabling its operation.
The recall comes after 646 complaints were reported by December 12, 2024, about the Speed Control Dial, including three incidents of significant injuries: a fractured hip, fractured tibia, and fractured malleolus bone.
These devices were manufactured and distributed through authorized dealers between August 17, 2023, and November 21, 2024. It was discovered that a material alteration involving the printed circuit board assembly in the Speed Control Dial could potentially lead to performance flaws, such as continuous drive, involuntary movement, loss of power, and failure to initiate driving.
The material modification causes the Speed Control Dial not to completely halt the drive unit when set to zero, risking unintended activation of the SmartDrive motor without deliberate user input, especially when the dial is at zero and the light flashes in standby mode.
Additionally, when the Speed Control Dial is turned forward from the zero position, the initiation of the SmartDrive motor movement is unexpectedly followed by a shutdown. In cases where the dial is moved forward from zero, there seems to be no activation of the SmartDrive motor.
The issues may arise for users of the affected Max Mobility/Permobil Speed Control Dial, potentially causing the SmartDrive motor to continue operating or stop without warning. Depending on the circumstances, users might suffer minor injuries such as skin irritation, cuts, or bruises, and more serious injuries like muscle or ligament strains or tears, bone fractures, or concussions.
Moreover, unintended activation or the inability to deactivate the power assist function may pose a serious injury risk, such as bone fractures, to individuals standing or sitting near the user.
Customers possessing the affected Speed Control Dial model numbers are advised to seek replacement units to ensure safety and functionality.
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