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Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial… recallZ-1117-2025 · Max Mobility LLC · initiated Dec 20, 2024

Class I Open, Classified All recalls posted in February 2025

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Max Mobility LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.

FDA root cause category: Component change control

What the company is doing

Initially Max Mobility notified consignees of their Urgent Medical Correction between the dates of 12/20/24 - 01/17/2025. Since this time, Max Mobility has expanded the recall due to recalled product that may have been inadvertently comingled with redesigned product and shipped after December 20, 2024. Starting 3/25/25, Max Mobility began reaching out to customer via phone, email and mail about the expansion. In addition, Max Mobility updated their press release on 4/7/2025 1. Click on the link or scan QR code to enter the portal within the letter 2. Complete requested portal information. 3. 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 or (b) provide end user contact information to Max Mobility through the online portal and we will contact them for you. 4. After acknowledgement, instructions for obtaining replacement SpeedControl Dial units will be provided. You will need the associated client ID provided in ATTACHMENT 1 of this letter when requesting SpeedControl Dial replacement(s). 5. Once the replacement SpeedControl Dial has been issued to the end user, you will be asked to verify that the correction was completed via the field action portal and destroy or return the effected SpeedControl Dial to Max Mobility.

Recall details

Recall number
Z-1117-2025
Recall class
Class I (most serious)
Status
Open, Classified
Initiated by the company
Dec 20, 2024
Posted by the FDA
Feb 11, 2025
Recalling firm
Max Mobility LLC
Quantity
unknown
Product code
ITI
FDA submissions
K151199
Distribution
US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY OUS: Sweden, Canada, Australia, Japan, New Zealand, Colombia, Argentina, Hong Kong, Canada, Mexico, Bermuda, South Korea, Chile

Product description

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

Code information (models, lots, serial numbers)

All serial numbers manufactured between August 17,2023 through November 21, 2024

Other devices under the same FDA submission

2 devices cleared under K151199 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 96086).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page