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FOR IMMEDIATE RELEASE: April 4, 2025
Company Address
Max Mobility/Permobil
300 Duke Drive
Lebanon, TN 37090
Telephone/Company Website
615-257-2930 / www.permobil.comExternal Link Disclaimer
Reason for Voluntary Field Correction
Max Mobility/Permobil has expanded the recall of the Speed Control Dial, a wired control option for the SmartDrive MX2+ Power Assist Device due to safety and performance concerns. The recall was originally initiated on December 20, 2024, and has been expanded to address recalled product that may have been inadvertently comingled with redesigned product and shipped after December 20, 2024. Those impacted by the expansion of the recall will be contacted with additional instructions. This recall, as expanded, impacts all Speed Control Dials manufactured and distributed between the dates of August 17, 2023, through March 10, 2025.
For FDA Original Press Release click on this link.
Max Mobility/Permobil has identified a material change with the printed circuit board assembly (PCBA) in the Speed Control Dial. The material change can cause performance issues such as:
- Continued drive: The Speed Control Dial does not fully stop the drive unit when rotated to the zero position.
- Involuntary movement: 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.
- Loss of power: 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.
- Failure to start driving: When the dial is rotated forward from the zero position, no SmartDrive motor activation occurs.
As of March 27, 2025, Max Mobility/Permobil has received 781 complaints associated with the Speed Control Dial. As of March 27, 2025, five (5) serious injuries have been reported for this issue. The reported serious injuries include a fractured hip, fractured tibia, fractured malleolus bone, broken ribs, and a concussion.
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