Speed Control Dial Component

  • Expanded recall due to potential safety and performance concerns
  • Company: Max Mobility, LLC.
  • Medical Devices
  • FDA
  • April 7, 2025

Product details

  • Speed Control Dial Component

Company announcement

Max Mobility/Permobil has expanded the recall of the Speed Control Dial for the SmartDrive MX2+ Power Assist Device due to safety and performance concerns.

The recall was expanded to address product that may have been inadvertently comingled with redesigned product and shipped after December 20, 2024.

The recall impacts all Speed Control Dials manufactured and distributed between August 17, 2023, through March 10, 2025.

Five serious injuries have been reported, including a fractured hip, fractured tibia, fractured malleolus bone, broken ribs, and a concussion.

Risk:

If an individual is using an impacted Max Mobility/Permobil Speed Control Dial, they may experience performance issues such as continued drive, unexpectedly initiating movement, or stopping unexpectedly, which could lead to minor and/or serious injuries. There is also a risk associated with individuals standing or sitting in close proximity to the end user, where unintentional activation and/or inability to turn off power assist could cause serious injury such as a bone fracture in an extremity.

Impacted states: Nationwide

Products:

- MX2-3DCK/MX2-3DC - The frame-mounted Speed Control

Contact

For more information, call 615-257-2930.

View the original FDA notice

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