Recall Z-2538-2025 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 | Sep 12, 2025 (initiated Aug 12, 2025) |
| Status | Open, Classified |
| Reason | Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries. |
| Root cause | Component design/selection |
| Action | On August 12, 2025, Permobil issued a "Urgent Medical Device Recall Expansion/Update" via email. This expansion supersedes the Class I recall ((Z-1116-2025, Z-1117-2025), initiated on December 20, 2024. Permobil asked consignees to take the following actions: 1. Immediately discontinue use of the SpeedControl dial to reduce the likelihood of a potentially hazardous or harmful situation. 1. Since all SpeedControl Dials are impacted by this recall, remove SpeedControl Dials from your sellable / distribution inventory 2. Use an alternate method to control the SmartDrive MX2+ Power Assist Devic |
| Quantity | 25,389 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: CAN, NZL, KOR, BMU, GBR, JPN, TWN, AUS, BRA, COL, MEX, ABW, SWE, CHL, ARG, HKG |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151199 | SmartDrive Wheelchair Power Assist Max Mobility, LLC, Jul 30, 2015 |