TOPIC: SmartDrive Speed Control Dial by Max Mobility/ Permobil: Recall Expansion - Due to the Motor Being Unresponsive to the User
AUDIENCE: Patient, Health Care Professional, Risk Manager
ISSUE: Max Mobility/Permobil has expanded the recall of the Speed Control Dial, a wired control option for the SmartDrive MX2+ Power Assist Device due to safety and performance concerns. The recall was originally initiated on December 20, 2024, and has been expanded to address recalled product that may have been inadvertently comingled with redesigned product and shipped after December 20, 2024. Those impacted by the expansion of the recall will be contacted with additional instructions. This recall, as expanded, impacts all Speed Control Dials manufactured and distributed between the dates of August 17, 2023, through March 10, 2025.
As of March 27, 2025, Max Mobility/Permobil has received 781 complaints associated with the Speed Control Dial. As of March 27, 2025, five (5) serious injuries have been reported for this issue. The reported serious injuries include a fractured hip, fractured tibia, fractured malleolus bone, broken ribs, and a concussion.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: Max Mobility/Permobil Brand - MX2-3DCK/MX2-3DC - The frame-mounted Speed Control is easily mounted to a wheelchair to allow for close access and easy pressing. The Speed Control Dial can be used to deactivate the SmartDrive motor, as well as provide a means of actively powering the motor.
For FDA Original Press Release click on this link.
RECOMMENDATIONS: To reduce the likelihood of a hazardous situation, discontinue use of the Speed Control Dial and utilize an alternate wired controller (Switch Control buttons or Switch Control with mono jack and mechanical switch) or wearable controller (compatible Apple Watch or Samsung Galaxy Watch Wear OS app).
If you have purchased a Speed Control Dial(s) with the above model numbers, you will need to request replacement Speed Control Dial units.
Use the QR code to access the field action portal at: https://hub.permobil.com/smartdrive-scd-voluntary-field-action.
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Click on the link or scan the QR code to enter the portal.
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Once you enter the portal, you will be asked to enter your contact information, select if you are a dealer or end user, and acknowledge that you have read and understood the Urgent Medical Device Correction letter.
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DEALERS: If you are a dealer and have distributed the affected product to someone else, you will be asked to select a transmission method. You may either (a) notify your end users directly and include a copy of this notice with your communication and the provider ID OR (b) provide end user contact information to Max Mobility/Permobil through the online portal and we will contact them for you.
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END USERS: If you are an end user, you will need to complete the end user portion of the requested information within the field action portal linked above.
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After acknowledgment, instructions for obtaining replacement Speed Control Dial units will be provided. You will need the associated provider ID provided in ATTACHMENT 1 of the letter in the portal when requesting Speed Control Dial replacement(s).
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Once the replacement Speed Control Dial has been issued, you will be asked to verify that the correction was completed via the field action portal and destroy or return the affected Speed Control Dial(s) to Max Mobility/Permobil.
Contact Information
- If you need assistance at any time, the portal will provide you with access to the Max Mobility/Permobil technical support team at (615) 257-2930.
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