Max Mobility, LLC is a subsidiary of Permobil. Max Mobility was acquired by Permobil in 2017.  Max Mobility is named in communications about this recall because it is the official establishment name on record with the U.S. FDA and associated with the SmartDrive MX2+ Power Assist medical device. 

The SpeedControl Dial is a wired component of the SmartDrive MX2+ Power Assist Device. The SpeedControl Dial connects to the SmartDrive MX2+ motor and is a rotary controller that allows a user to start, stop, and control the speed of the SmartDrive MX2+ Power Assist Device.

Due to safety and performance concerns that have been identified in the SpeedControl Dial, Max Mobility/Permobil has decided to remove it completely from the market.

All SpeedControl Dials are impacted by these safety and performance concerns. Specific part numbers associated with SpeedControl Dials are listed below:

• MX2-850-3DC (SpeedControl Dial shipped in conjunction with a SmartDrive MX2+ Device)
• MX2-3DC (SpeedControl Dial shipped as an independent component/spare part)
• MX2-3DCMC (SpeedControl Dial shipped after the first market action/recall was initiated)

No. While investigating a new complaint received during the existing/prior recall, Max Mobility/Permobil identified a new design issue that can lead to safety and performance concerns with the SpeedControl Dial. Since the design issue has been part of the SpeedControl Dial since its introduction to the market in April 2022, Max Mobility/Permobil made the decision to recall all SpeedControl Dials out of an abundance of caution. This is a new recall that applies to all SpeedControl Dials, including those that were shipped as replacements under the existing recall.

If you have a SpeedControl Dial, please take the following actions immediately:

1. Immediately discontinue use of the SpeedControl Dial to reduce the likelihood of a potentially hazardous or harmful situation.
2. Use an alternate method to control the SmartDrive MX2+ Power Assist Device. Alternate controls include:

• A wired SwitchControl, which can be ordered with a mono jack port to connect with an optional Buddy Button.
• Wirelessly through the SmartDrive MX2+ App utilising an Apple Watch or Samsung Galaxy Watch. A list of compatible wearable devices can be found here.

3. Please click on the Recall Portal above to acknowledge the recall and commence the market action.

You may also contact Customer Service at 0800 115 222 or SmartDriveAction_NZ@permobil.com for assistance.

If you possess or distributed a SpeedControl Dial, please take the following actions immediately:

1. Since all SpeedControl Dials are impacted by this recall, remove SpeedControl Dials from your sellable/distribution inventory.
2. Please click on the Recall Portal above to acknowledge the recall and commence the market action.

The serial number of the SmartDrive MX2+ Power Assist Device is located under the front nose of the device.

No, the recall does not apply to the SmartDrive MX2+ Power Assist Device. The recall only applies to the SpeedControl Dial controller.

Yes. You can still use the SmartDrive MX2+ Power Assist Device with a wired SwitchControl, which can be ordered with an optional Buddy Button, and/or the SmartDrive MX2+ App on your personal wearable device.

No. If you have a SpeedControl Dial, you should stop using it, remove it from your SmartDrive MX2+ Power Assist Device, and cut the cord to destroy the product. However, if you wish to return the SpeedControl Dial to Permobil, you may do so by contacting Customer Service at 0800 115 222 or SmartDriveAction_NZ@permobil.com and we will provide additional information on how to send it back for quarantine and destruction.

Once you destroy or return your SpeedControl Dial, you are required to complete the attached Verification of Disposition Form and email it back to SmartDriveAction_NZ@permobil.com. 

While we will have resources to help you learn more about the SwitchControl and wearable device options, it is recommended to reach out to your SmartDrive dealer or prescribing clinician to determine which controller is best for you.

Max Mobility/Permobil will provide a SwitchControl or a SwitchControl with Buddy Button as a replacement to your SpeedControl Dial, free of charge. Please click on the Recall Portal above to start this process.

Permobil will pay the shipping cost to send your SpeedControl Dial back to us if necessary. Please contact Customer Service at 0800 115 222 or SmartDriveAction_NZ@permobil.com.

To reduce the likelihood of a potentially hazardous or harmful situation, Max Mobility/Permobil advises you to immediately discontinue use of the SpeedControl Dial and use an alternative method to control your SmartDrive MX2+ Power Assist Device. If you voluntarily disregard this advice, please be aware that the design issue with the SpeedControl Dial can result in an intermittent electrical connection between the Dial and the SmartDrive MX2+ motor, which can cause the following performance issues to 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.

No. Max Mobility/Permobil is no longer offering the SpeedControl Dial.

No. Max Mobility/Permobil is not providing repairs or spare parts for the SpeedControl Dial.

If you choose to receive a SwitchControl to use with your SmartDrive MX2+ Power Assist Device, we will arrange shipment as soon as possible once stock is available. We are actively working to expedite orders and assembly and will keep you updated on your order status. Rest assured, providing your replacement SwitchControl quickly is our priority.

Please click on the Recall Portal above or contact Customer Service at 0800 115 222 or SmartDriveAction_NZ@permobil.com for assistance.

Please see the videos in the Resources tab on this page for additional details.

Max Mobility/Permobil, and it’s authorised dealer network, will make reasonable attempts to notify consumers using alternative contact methods, such as by telephone, if initial email notifications are unsuccessful. The purpose of these phone calls is to ensure consumers are aware of the recall and that the recall is effective. Even if you have been contacted previously as part of an earlier SpeedControl Dial recall, this is a new/expanded recall that impacts all SpeedControl Dials, which will result in additional communications from Max Mobility/Permobil. We request your assistance in acknowledging receipt of the recall and our Customer Service team is available to assist you with replacing your SpeedControl Dial with a SwitchControl.