Max Mobility/Permobil has initiated an urgent recall of SpeedControl Dials used in their SmartDrive MX2+ Power Assist Devices. This action follows an FDA classification labeling the recall as the most severe, indicating the devices could lead to serious injury or death.
What changed?
The recall affects all SpeedControl Dials, including those replaced during earlier recall efforts. These devices have been found to exhibit unexpected behavior due to intermittent electrical connections with the SmartDrive MX2+ motor. Problems include continued drive when attempting to stop or involuntary movement when the dial is at zero position in stand-by mode. Such events create significant safety risks for both device users and individuals nearby.
Who is affected?
This recall is relevant for both end-users and distributors of SmartDrive MX2+ Power Assist Devices across the United States. Users of wheelchairs fitted with the SmartDrive MX2+ component—particularly using a SpeedControl Dial—are at risk of injury, ranging from minor incidents such as scrapes to severe harm like fractures.
As of July 29, 2025, the manufacturer had documented two serious injuries linked to these devices, although no fatalities had occurred.
Actions required for users and distributors
End-User Safety Measures
All end-users are strongly advised to stop using SpeedControl Dials immediately. Instead, they should switch to alternative control mechanisms. Options include:
- Wired SwitchControl devices with mono jack ports for Buddy Button compatibility.
- Wireless connection to compatible Apple or Samsung Galaxy watches using the SmartDrive MX2+ app.
Users should contact Max Mobility/Permobil for instructions on receiving replacements and properly disposing of existing SpeedControl Dials.
Distributor Responsibilities
Distributors must ensure their inventories no longer include SpeedControl Dials. Additionally, they must either notify affected end-users directly or provide client contact information to Max Mobility/Permobil through an online portal for direct notification.
Manufacturer actions
Max Mobility/Permobil is addressing the issue by replacing the flawed SpeedControl Dials with SwitchControl devices. They began reaching out to affected customers with urgency letters on August 12, 2025. Replacement instructions, along with directions for proper disposal of the SpeedControl Dials, are provided upon acknowledgment of the recall letter.
The manufacturer has committed to resolving the issue promptly to minimize risk.
Conclusion: Immediate steps for user and distributor safety
This recall underscores the importance of ensuring medical device safety and reliability. Users should stop using SpeedControl Dials immediately and switch to the recommended alternative control methods. Distributors must ensure proper communication and inventory actions to safeguard the public.
Disclaimer
This article provides regulatory information about medical device recalls and does not constitute legal or professional advice. Please consult the FDA or the manufacturer directly for specific guidance.
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/recall-alert-max-mobilitypermobil-removes-all-speedcontrol-dials-used-smartdrive-mx2-power-assist