Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheel
FDA device recall Z-1117-2025 · posted 2025-02-11 · Open, Classified
Recall details
- Recalling firm
- Max Mobility LLC
- 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.
- Action taken
- 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.
- Root cause
- Component change control
- Status
- Open, Classified
- Product code
- ITI
- Quantity affected
- 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, N
- Date initiated
- 2024-12-20
- Date posted
- 2025-02-11
- Location
- Lebanon, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SmartDrive Wheelchair Power Assist (K151199) | Max Mobility, LLC | 2015-07-30 |