Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall Smart Drive MX2 SpeedControl Dial

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 1 Device Recall Smart Drive MX2 SpeedControl Dialsee related information
Date Initiated by FirmAugust 12, 2025
Date PostedSeptember 12, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2539-2025
Recall Event ID 97356
510(K)NumberK151199 
Product Classification Wheelchair, powered - Product Code ITI
ProductMax Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Code Information All Serial Numbers distributed between the dates of April 25, 2022 - July 8, 2025
Recalling Firm/
Manufacturer		 Max Mobility LLC
300 Duke Dr
Lebanon TN 37090-8115
For Additional Information ContactAudra Watt
800-637-2980
Manufacturer Reason
for Recall		Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.
FDA Determined
Cause 2		Component design/selection
ActionOn August 12, 2025, Permobil issued a "Urgent Medical Device Recall Expansion/Update" via email. This expansion supersedes the Class I recall ((Z-1116-2025, Z-1117-2025), initiated on December 20, 2024. Permobil asked consignees to take the following actions: 1. Immediately discontinue use of the SpeedControl dial to reduce the likelihood of a potentially hazardous or harmful situation. 1. Since all SpeedControl Dials are impacted by this recall, remove SpeedControl Dials from your sellable / distribution inventory 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 utilizing a Apple iWatch or Samsung Galaxy watch. 3.Immediately contact any customers you have distributed the device to and provide a copy of this notice. It is also recommended that this notice be posted in your clinic/facility 4. You are required to acknowledge that you received this Urgent Medical Device Recall letter. Please complete within 10 days of receipt of the letter. Please use the QR code below to access the field action portal to record your acknowledgement
Quantity in Commerce15,834 units
DistributionUS: 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: CAN, NZL, KOR, BMU, GBR, JPN, TWN, AUS, BRA, COL, MEX, ABW, SWE, CHL, ARG, HKG
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = ITI
-
-