Max Mobility/Permobil Speed Control Dial Component recalled due to Safety Concerns, USA

United States

Max Mobility/Permobil has voluntarily expanded its recall of the SpeedControl Dial, a wired control option for the SmartDrive MX2+ Power Assist Device, due to safety and performance concerns. This voluntary action applies to all SpeedControl Dials manufactured and distributed between the dates of April 25, 2022 to July 08, 2025. The affected devices were distributed in the United States.

Relation to Existing/Prior Recall: A Class I recall (Z-1116-2025, Z-1117-2025), RES # 96086 was originally initiated on December 20, 2024 to address a material change with the printed circuit board assembly (PCBA) in SpeedControl Dials manufactured and distributed between the dates of August 17, 2023 and November 21, 2024. The recall was later expanded on March 28, 2025, and included all units manufactured and distributed from August 17, 2023 up to March 10, 2025. Max Mobility/Permobil received 781 complaints associated with PCBA design. Of these complaints, five (5) were for serious injuries, involving fractured or broken bones and a concussion.

Affected Product: All SpeedControl Dials are impacted by this issue. Specific part numbers associated with SpeedControl Dials are shown below:
Part Number:
1) MX2-3DCK
2) MX2-3DC
3) MX2-3DCMC

Reason for Expanded Voluntary Field Removal: Through ongoing complaint monitoring and subsequent investigation, Max Mobility/Permobil identified a design issue with the SpeedControl Dial that may lead to unexpected behavior of the SmartDrive MX2+ motor. This design issue has been part of the SpeedControl Dial since it was first introduced to the market in April 2022 and impacts all SpeedControl Dials manufactured and distributed, which occurred between April 25, 2022 to July 08, 2025, if there is an intermittent electrical connection between the SpeedControl Dial and SmartDrive MX2+ motor, the following performance issues could occur:

- Continued drive: The SmartDrive MX2+ Power Assist Device fails to fully stop when the SpeedControl Dial is pressed inward.
- Involuntary movement: Unintended activation of the SmartDrive MX2+ motor without intentional user input to the SpeedControl Dial while the dial is at zero position and dial light is flashing in stand-by-mode.

Max Mobility/Permobil has identified 54 complaints that may be associated with this issue. Of these complaints, two (2) involve serious injuries related to bone fractures.

Risk to Health: If an individual is using a Max Mobility/Permobil SpeedControl Dial to control their SmartDrive MX2+ Power Assist Device and experiences one of the performance concerns identified above, they may experience continued drive and/or involuntary movement. Depending on the scenario, this could lead to minor and/or serious injuries. A minor injury, such as a cut, bruise, scrape, or general soreness, could occur if one of these scenarios occurs at a low overall speed. If a user is travelling at a fast rate of speed and one of these scenarios occurs, there is a potential for serious injury, such as a bone fracture.

There is also a potential risk associated with individuals who may be in close proximity to a user of a SpeedControl Dial if one of these performance failure scenarios were to occur, as the wheelchair powered by the SmartDrive MX2+ Power Assist Device could run or bump into another individual and/or roll over their toes or another extremity.

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/max-mobility-permobil-announces-worldwide-expanded-recall-and-removal-all-speedcontrol-dials-market