Class 1 Device Recall Smart Drive MX2 SpeedControl Dial

• Date Initiated by Firm: December 20, 2024
• Date Posted: February 11, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1116-2025
• Recall Event ID: 96086
• 510(K)Number: K151199
• Product Classification: Wheelchair, powered - Product Code ITI
• Product: Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
• Code Information: All serial numbers manufactured between August 17,2023 through November 21, 2024
• Recalling Firm/ Manufacturer: Max Mobility LLC; 300 Duke Dr; Lebanon TN 37090-8115
• For Additional Information Contact: Audra Watt; 800-736-0925
• Manufacturer Reason for Recall: Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.
• FDA Determined Cause: Component change control
• Action: On December 20, 2024, Max Mobility notified distributors verbally and by email about the product recall. On January 10, 2025 and January 17, 2025, Max Mobility issued a "Urgent Medical Device Correction" notification to affected consignees via E-Mail. Max Mobility also issued a press release on their website on January 17, 2025. Max Mobility asked consignees to take the following action: 1. Click on the link or scan 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. 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 or (b) provide end user contact information to Max Mobility through the online portal and we will contact them for you. 4. After acknowledgement, instructions for obtaining replacement SpeedControl Dial units will be provided. You will need the associated client ID provided in ATTACHMENT 1 of this letter when requesting SpeedControl Dial replacement(s). 5. Once the replacement SpeedControl Dial has been issued to the end user, you will be asked to verify that the correction was completed via the field action portal and destroy or return the effected SpeedControl Dial to Max Mobility.
• Quantity in Commerce: 11,891 units
• Distribution: US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY OUS: Sweden, Canada, Australia, Japan, New Zealand, Colombia, Argentina, Hong Kong, Canada, Mexico, Bermuda, South Korea, Chile
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = ITI