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SmartDrive Recall

SpeedControl Dial Field Control FAQs & Resources

Why am I being contacted?

You are being contacted due to a recall involving the SpeedControl Dial, a wired control option for the SmartDrive power assist device.

What is the difference between a recall and a voluntary field correction?

A voluntary field correction is a type of recall. The terms "voluntary field correction" and "recall" can be used interchangeably in communications. Permobil's decision to proactively address this quality issue in the field was voluntary and not mandated by the FDA.

What is being addressed by this recall?

Max Mobility/Permobil has identified a material change with the printed circuit board assembly (PCBA) in the SpeedControl Dial resulting in inconsistent performance issues. The recall strategy will provide a redesigned SpeedControl Dial to address these intermittent performance issues on any new orders, as well as units already in the field.

Is this a recall on SmartDrive power assist device?

No, this is a recall on the SpeedControl Dial, a wired control option for SmartDrive. The SmartDrive power assist device is not being recalled.

How do I get my replacement dial?

There are multiple ways to obtain a replacement:

- Follow the steps listed on our website by filling out the survey above to receive your replacement dial.

- Reach out to our customer experience team at (800) 736-0925

- Call the equipment provider that was used when purchasing your SpeedControl Dial

Will the FDA reach out directly to me?

Since this is a Class 1 recall, the FDA may reach out directly to a customer via phone call or visit to a customer’s location to verify effectiveness. This is routine for the FDA and if you have any questions or concerns, please reach out to the Permobil customer experience team at (800) 736-0925.

Who received notifications?

Notification letters were sent to the delivery addresses and contacts on file at Max Mobility/Permobil. In many instances, these addresses were specific equipment provider branches, and therefore corporate headquarters of the equipment provider may not have been notified.

How else has the market been notified of the recall?

Both Permobil and the FDA issued press releases in order to inform the larger market of the SpeedControl Dial Recall. To read the full press releases visit:

- Permobil Press Release

- FDA Press Release

Where do I locate my SmartDrive Serial Number?

The serial number of the SmartDrive is located under the front nose of the device.

SmartDrive Serial Number Image

 

What other methods can I use to control my device?

Max Mobility/Permobil offers multiple control methods for SmartDrive including SwitchControl, SwitchControl with Mono jack (compatible with the buddy button and other mechanical switches), and the SmartDrive MX2+ App for compatible Apple and Samsung Galaxy smartwatches.

When will I get my replacement SpeedControl Dial?

Orders are currently being shipped out, and you can expect to receive your new dial within standard lead times. Please note that demand for the dial may be higher than normal, and we may encounter part shortages through this process. We will get you your replacement as soon as possible.

Do I need to return my old SpeedControl Dial?

Once you receive your new dial you will be asked to dispose of it yourself following the instructions in the market correction letter.

Where can I locate my Provider ID?

The Provider ID is located on the letter you received from Permobil. If you did not receive a letter, call Permobil customer experience or your provider for this information.

SpeedControl Instruction Manual
SmartDrive MX2+ User Manaul
SmartDrive Smartwatch Compatibility Guide
SpeedControl Dial FAQs

How to SpeedControl Dial 

 

How to remove and install your SpeedControl Dial
How to remove and install your SpeedControl Dial with an extension arm attachment

SpeedControl Dial Disposition Process