Speed Control Dial Component

  • Due to potential safety and performance concerns.
  • Company: Max Mobility, LLC.
  • Medical Devices
  • FDA
  • January 14, 2025

Product details

  • Speed Control Dial Component

Company announcement

Max Mobility/Permobil has issued a nationwide recall for the Speed Control Dial component used with the SmartDrive MX2+ Power Assist Device.

The recall was initiated due to a material change that can cause performance issues such as continued drive, involuntary movement, loss of power, or failure to start driving.

As of December 12, 2024, there have been 646 complaints and three serious injuries reported, including fractured hip, fractured tibia, and fractured malleolus bone.

Risk:

If an individual is using an impacted Max Mobility/Permobil Speed Control Dial, they may experience one of the above performance issues. This could result in the SmartDrive motor continuing to run, unexpectedly initiating movement, or stopping unexpectedly. Depending on the scenario, this could lead to minor and/or serious injuries: Minor injuries such as skin irritation, minor cuts, and bruises. Serious injuries such as a muscle or ligament strain or tear, bone fracture in an extremity, and/or concussion. 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 Speed Control Dial

Contact

For more information, call 800-736-0925.

View the original FDA notice

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