Urgent Voluntary Medical Device Correction | SmartDrive SpeedControl Dial

Nashville TN – Max Mobility / Permobil is issuing a voluntary medical device field correction for the SpeedControl Dial component utilized with the SmartDrive MX2+ Power Assist Device due to potential safety and performance concerns. Impacted products were manufactured between August 17, 2023 through November 21, 2024.

Max Mobility / Permobil has identified a material change with the printed circuit board assembly (PCBA) in the SpeedControl Dial. This could result in the SmartDrive motor continuing to run, unexpectedly initiating movement, or stopping unexpectedly. Depending on the scenario, this could lead to serious injury.

Our top priority is ensuring safety and end-user satisfaction. For this reason, Max Mobility/Permobil has voluntarily implemented this correction to guarantee the safe and optimal performance of our products.

Affected Product

The specific model numbers impacted by this issue are shown below

• MX2-3DCK
• MX2-3DC 

Reason for Voluntary Field Correction

This material change has resulted in performance issues with the SpeedControl Dial, such as:

• Continued drive: The SpeedControl Dial does not fully stop the drive unit when rotated to zero position. 
• Involuntary movement: Unintended activation of the SmartDrive motor without intentional user input while the SpeedControl Dial is at zero position and dial light is flashing in stand-by-mode.
• Loss of power: When the SpeedControl Dial is rotated forward from zero position, SmartDrive motor movement is initiated, and then the SpeedControl Dial unexpectedly shuts down. 
• Failure to start driving: When the dial is rotated forward from zero position, no SmartDrive motor activation occurs.

Required Actions

If you have purchased a SpeedControl Dial(s) with the above model numbers, you will need to request replacement SpeedControl Dial units.

1.  Click on the link: https://hub.permobil.com/smartdrive-scd-voluntary-field-action to access the field action portal.

2.  Once you enter the portal, you will be asked to enter your contact information, select if you are a dealer or end user, and acknowledge that you have read and understood the Urgent Medical Device Correction letter.

3.  DEALERS: If you are a dealer and have distributed the affected product to someone else, you will be asked to select a transmission method. You may either (a) notify your end users directly and include a copy of this notice with your communication and the provider ID OR (b) provide end user contact information to Max Mobility / Permobil through the online portal and we will contact them for you.

4.  END USERS: If you are an end user, you will need to complete the end user portion of the requested information within the field action portal linked above.

5.  After acknowledgement, instructions for obtaining replacement SpeedControl Dial units will be provided. You will need the associated provider ID provided in ATTACHMENT 1 of the letter in the portal when requesting SpeedControl Dial replacement(s).

6.  Once the replacement SpeedControl Dial has been issued, you will be asked to verify that the correction was completed via the field action portal and destroy or return the effected SpeedControl Dial(s) to Max Mobility / Permobil.

Temporary solutions

While a user is waiting to receive their corrected SpeedControl Dial, the following actions can be taken immediately to reduce the likelihood of a hazardous situation: 

• Discontinue use of the SpeedControl Dial and utilize an alternate 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). 

• Possible actions for each performance issue include: 
• Continued drive: Press the face of the SpeedControl Dial. This is an alternative stop option to disengage power assist.  
• Involuntary movement: Press the face of the SpeedControl Dial. This is an alternative stop option to disengage power assist.  
• Loss of power: Rotate the SpeedControl Dial back to the zero position and reengage power assist.  
• Failure to start driving: No in-field action, a replacement is required. 
• Another potential action to the above issues is to swap the switch on the rear of the dial from” R” (right) to “L” (left). While this results in the controls of the dial performing opposite of what it does when set to “R”, this has been shown to address performance issues in some scenarios.  

Contact Information

If at any time you need assistance, the portal will provide you with access to the Max Mobility / Permobil technical support team at (800) 736-0925.

Any adverse events experienced with the use of this product may be reported using one of the following options: 

• Online: By completing and submitting the report online at https://www.accessdata.fda.gov/scripts/medwatch 

• Regular mail or Fax: Download the form from www.fda.gov/MedWatch/getforms.htm or call 800-332-1088 to request a reporting form, then complete and mail it to the address on the pre-addressed form or submit by fax to 800-332-0178. 

We are voluntarily issuing this Urgent Medical Device Correction, and the U.S. Food and Drug Administration has been notified of this action.