Recall Z-1116-2025 ยท ITI Wheelchair, Powered
Max Mobility LLC
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
| Date | Feb 11, 2025 (initiated Dec 20, 2024) |
| Status | Open, Classified |
| 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 informa |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151199 | SmartDrive Wheelchair Power Assist Max Mobility, LLC, Jul 30, 2015 |