FDA Medical Device Recalls (openFDA)
Max Mobility LLC: Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
- Recall number
- Z-1117-2025
- Recalling firm
- Max Mobility LLC
- Product
- Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
- Status
- Open, Classified
- Initiated
- 2024-12-20
- Posted
- 2025-02-11
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Component change control
- Action
- Initially Max Mobility notified consignees of their Urgent Medical Correction between the dates of 12/20/24 - 01/17/2025. Since this time, Max Mobility has expanded the recall due to recalled product that may have been inadvertently comingled with redesigned product and shipped after December 20, 2024. Starting 3/25/25, Max Mobility began reaching out to customer via phone, email and mail about the expansion. In addition, Max Mobility updated their press release on 4/7/2025 1. Click on the link or scan QR code to enter the portal within the letter 2. Complete requested portal information. 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
- unknown
- 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
- Lot, serial or model codes
- All serial numbers manufactured between August 17,2023 through November 21, 2024
- 510(k) numbers
- ["K151199"]
- PMA numbers
- not on file
- Product code
- ITI
- Firm FEI
- 3008370857
- Firm city
- Lebanon
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28