U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Medical Devices
  3. Medical Device Safety
  4. Medical Device Recalls
  5. Power Assist Device Recall: Max Mobility/Permobil Removes SpeedControl Dial Component Used with SmartDrive MX2+ Power Assist Device Due to Risk for Motor to Be Unresponsive to the User
  1. Medical Device Recalls

Power Assist Device Recall: Max Mobility/Permobil Removes SpeedControl Dial Component Used with SmartDrive MX2+ Power Assist Device Due to Risk for Motor to Be Unresponsive to the User

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. 

Affected Product

Max Mobility/Permobil Speed Control Dial Component
  • Product Name: Speed Control Dial Component Used with the SmartDrive MX2+ Power Assist Device
  • Part Number: MX2-3DCK, MX2-3DC
  • Serial Numbers: All manufactured from August 17, 2023 to November 21, 2024

What to Do  

  • Stop using the SpeedControl Dial immediately.
  • Switch to an alternate controller such as a wired or wearable controller.

If one of the performance issues occurs before a corrected SpeedControl Dial is received:  

  • Press the face of the SpeedControl Dial if continued drive or involuntary movement occurs.
  • Rotate the SpeedControl Dial back to zero position and reengage power assist if power to the device is lost.
  • Wait for a replacement if the device fails to start driving.

On December 20, 2024, Max Mobility/Permobil sent all affected customers an Urgent Medical Device Correction letter recommending the following actions:

  • Stop using the SpeedControl Dial.
  • Use another type of wired controller (SwitchControl buttons or SwitchControl with mono jack and mechanical switch) or wearable controller (compatible Apple Watch or Samsung Galaxy Watch once Wear OS app is released).
  • Request replacement SpeedControl Dial units through the field action portal at: https://hub.permobil.com/smartdrive-scd-voluntary-field-action.
  • Enter the portal and:
    • Enter your contact information
    • Select if you are a dealer or end user
    • Acknowledge you have read and understood the Urgent Medical Device Correction letter.
  • Contact Max Mobility/Permobil technical support team at 800-736-0925 at any time for assistance.

Additional actions for customers/end users

  • Complete the end user section of the requested information found at the recall portal.
  • Instructions for getting replacement SpeedControl Dial units will be provided after acknowledging the letter in the recall portal.
    • Make sure to have your associated provider ID (found in the letter’s attachment 1) when requesting replacement(s).
  • Use the field action portal once the replacement SpeedControl Dial has been issued to verify the correction was finished.
  • Destroy affected SpeedControl Dials or return them to Max Mobility/Permobil.

Additional actions for distributors/dealers

  • Dealers who have distributed affected product will be asked to select a transmission method to notify end users:
    • Notify directly, including a copy of the notice with your communication and the provider ID
    • Provide end user contact information to Max Mobility/Permobil through the online portal for the firm to contact them.

Reason for Recall  

Max Mobility/Permobil is recalling the SpeedControl Dial component used with the SmartDrive MX2+ Power Assist Device due to a circuit board issue that may cause the motor to be unresponsive to the user. Specifically, the device may continue to drive, move on its own without user input, lose power, or fail to start driving.

The use of affected product may cause serious adverse health consequences for users and bystanders, including skin irritation, minor cuts, bruises, muscle or ligament strain or tear, bone fractures, concussion, and death.  

There have been 13 reported injuries. There have been no reports of death. 

Device Use

The Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial is used with the SmartDrive MX2+ Wheelchair Power Assist component. The MX2+ is attached to a mechanical wheelchair and provides motorized assistance (power assist) to move the wheels when the user pushes on the chair’s hand rails. 

Contact Information  

Customers in the U.S. with questions about this recall should contact Max Mobility / Permobil technical support team at (800) 736-0925. 

Full List of Affected Devices  

Additional FDA Resources  

Additional Company Resources  

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. 

Subscribe to Medical Device Safety and Recalls

Sign up to receive email updates on medical device recalls, safety communications, and other safety information.

Back to Top