Max Mobility, LLC., in cooperation with Permobil, has announced a nationwide recall of the Speed Control Dial component used in the SmartDrive MX2+ Power Assist Device. This voluntary recall, initiated due to potential safety and performance concerns, was made public through an FDA announcement dated January 17, 2025.
The recall addresses issues with a material change in the printed circuit board assembly of the Speed Control Dial, which may result in multiple performance issues including continued drive when supposed to stop, involuntary motor activation, loss of power, and failure to start driving. As of December 12, 2024, the company has received 646 complaints and reports of three serious injuries related to these malfunctions, including fractures of the hip, tibia, and malleolus bone.
Impacted products were manufactured and distributed between August 17, 2023, and November 21, 2024, through authorized dealers. The risk involves minor injuries such as skin irritation and serious injuries including bone fractures and concussions, potentially affecting not just users but those around them.
Affected customers are urged to use the QR code provided in the company’s communication to access the field action portal for a replacement unit. Max Mobility/Permobil has detailed steps for both dealers and end users to follow in securing replacements, including verifying the completion of the correction.
For assistance, customers can contact Max Mobility/Permobil technical support available Monday to Friday, or report adverse reactions to the FDA’s MedWatch program.
