Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Medical Devices
Reason for Announcement:

Recall Reason Description

Due to potential safety and performance concerns.

Company Name:
Max Mobility, LLC.
Brand Name:

Brand Name(s)

Product Description:

Product Description

Speed Control Dial Component

Company Announcement

Reason for Voluntary Field Correction

Max Mobility/Permobil has initiated a nationwide recall of the Speed Control Dial component used with the SmartDrive MX2+ Power Assist Device due to potential safety and performance concerns. Customers were notified by email on December 20, 2024.

Max Mobility/Permobil has identified a material change with the printed circuit board assembly 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 December 12, 2024, we have received 646 complaints associated with the Speed Control Dial. Additionally, three serious injuries have been reported for this issue. The reported serious injuries include a fractured hip, fractured tibia, and fractured malleolus bone. Impacted products were manufactured and distributed through authorized dealers for purchase by consumers between August 17, 2023, and November 21, 2024.

Risk to Health

If an individual is using an impacted Max Mobility/Permobil Speed Control Dial, they may experience one of the above performance issues. This could result in the SmartDrive motor continuing to run, unexpectedly initiating movement, or stopping unexpectedly. Depending on the scenario, this could lead to minor and/or serious injuries:

  • Minor injuries such as skin irritation, minor cuts, and bruises.
  • Serious injuries such as a muscle or ligament strain or tear, bone fracture in an extremity, and/or concussion.
  • There is also a risk associated with individuals standing or sitting in close proximity to the end user, where unintentional activation and/or inability to turn off power assist could cause serious injury such as a bone fracture in an extremity.

Affected Product

  • Max Mobility / Permobil Brand - MX2-3DCK/MX2-3DC - The frame-mounted Speed Control is easily mounted to a wheelchair to allow for close access and easy pressing. The Speed Control Dial can be used to deactivate the SmartDrive motor, as well as provide a means of actively powering the motor.

Required Actions

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

Use the QR code to access the field action portal at: https://hub.permobil.com/smartdrive-scd-voluntary-field-action.

  1. Click on the link or scan the QR code to enter the 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 acknowledgment, instructions for obtaining replacement Speed Control Dial units will be provided. You will need the associated provider ID provided in ATTACHMENT 1 of the letter in the portal when requesting Speed Control Dial replacement(s).
  6. Once the replacement Speed Control 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 affected Speed Control Dial(s) to Max Mobility / Permobil.

Contact Information

If you need assistance at any time, the portal will provide you with access to the Max Mobility / Permobil technical support team at (800) 736-0925. Max Mobility/Permobil technical support is available Monday - Friday from 8:00 am CT to 5:00 pm CT.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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

Audra Watt, VP Marketing, 
Permobil Americas
Telephone: +1 615 992 4221
Email: audra.watt@permobil.com

Company Contact Information

Consumers:
Max Mobility/Permobil technical support
800-736-0925