Z-1116-2025Class I

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive...

Name: Z-1116-2025 Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive...
Creator: Max Mobility LLC
Published: 2024-12-20
License: https://open.fda.gov/license/

Permobil, AB / initiated 2024-12-20 / Open, Classified

FDA source

Max Mobility LLC began a recall of Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component on 2024-12-20. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1116-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-12-20
Posted: 2025-02-11
Recalling firm: Permobil, AB
Product: Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Product code: ITI Wheelchair, Powered
Reason for recall: 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: Component change control
Action: 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.
Quantity in commerce: unknown
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 codes and lots: All serial numbers manufactured between August 17,2023 through November 21, 2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1116-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1116-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-11
Z-1117-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-11

Product code ITI

K151199Class IISmartDrive Wheelchair Power AssistMax Mobility, LLC / cleared 2015-07-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)