Your browser is out-of-date!

Update your browser to view this website correctly. View list of available browsers

Urgent Medical      Device for Product Correction

Please find information and support on this page for the voluntary medical device field correction for the SpeedControl Dial, utilised with SmartDrive MX2+ Power Assist Device. 

  • Please note: As of 12 August 2025, the below has been superseded by the global SpeedControl Dial recall. More information on this updated recall can be found here.

URGENT MEDICAL DEVICE FOR PRODUCT CORRECTION

Permobil New Zealand, following consultation with MedSafe, is undertaking a voluntary medical device product correction on the SpeedControl Dial component,
utilised with the SmartDrive MX2+ Power Assist Device (WAND reference 210831-WAND-6XI4GS). 

Reason for the Device Correction

The SpeedControl Dial is a wired control option for the SmartDrive Power Assist Device. Through market feedback and subsequent investigation, Permobil has identified a material change with the printed circuit board assembly (PCBA) in the SpeedControl Dial resulting in inconsistent performance issues. The following are scenarios that some users may experience:  

  • Continued drive: The SpeedControl Dial does not fully stop the drive unit when rotated to zero position.  
  • Involuntary movement: Unintended activation of the SmartDrive motor without intentional user input while the SpeedControl Dial is at zero position and dial light is flashing in stand-by-mode. 
  • Loss of power to SpeedControl Dial: When the dial is rotated forward from zero position, SmartDrive motor movement is initiated, and then the SpeedControl Dial unexpectedly shuts down.  
  • Failure to start driving: When the dial is rotated forward from zero position, no SmartDrive motor activation occurs. 
Risk to Health
If an individual is using an impacted SpeedControl Dial, they may experience one of the above performance issues. This could result in the SmartDrive motor continuing to run, unexpectedly initiating movement, or stopping unexpectedly. Depending on the scenario, this could lead to serious injury.  
Affected Product

Impacted products were manufactured between August 2023 through to November 2024.

The specific model number impacted by this issue are shown below: 

Part Number
MX2-3DC

 

Actions Required

You should have received a formal communication from Permobil, containing a Provider Acknowledgement Form, an End User Letter, and a Verification of Completion form. 

If you cannot locate these documents, please contact nz_qualmgt@permobil.com. 

While a user is waiting to receive their corrected SpeedControl Dial, they can continue to use their current SpeedControl Dial provided they are not experiencing any of the above performance issues.

However, if they are experiencing the above performance issues, the following actions can be taken immediately to reduce the likelihood of a hazardous situation: 

  • Discontinue use of the SpeedControl Dial and utilise an alternate wired controller (SwitchControl buttons or SwitchControl with mono jack and mechanical switch) or wearable controller (compatible Apple Watch or Samsung Galaxy Watch)
  • Possible actions for each performance issue include:
    • Continued drive: Press the face of the SpeedControl Dial. This is an alternative stop option to disengage power assist.  
    • Involuntary movement: Press the face of the SpeedControl Dial. This is an alternative stop option to disengage power assist.  
    • Loss of power to SpeedControl Dial: Rotate the SpeedControl Dial back to the zero position and reengage power assist.
    • Failure to start driving: No in-field action, a replacement is required. 

    • Another potential action to the above issues is to swap the switch on the rear of the dial from "R" (right) to "L" (left). While this results in the controls of the dial performing opposite of what it does when set to "R", this has been shown to address the performance issues in some scenarios. 
Request for Replacement Form - For Provider Use Only

Once a replacement SpeedControl Dial is supplied to a provider by Permobil, the provider has a 90-day period to complete the exchange and return the Verification of Completion form. If the provider does not adhere to this timeline, Permobil reserves the right to invoice the provider for the SpeedControl Dial unless otherwise agreed.

*Please note: if multiple Purchase Orders, serial numbers and end user details are required, please download and complete spreadsheet, then return to Permobil via "File Upload" option found at the bottom of this form. 

 

Contact Information

If you have any questions, please contact Permobil New Zealand on 0800 115 222 or nz_qualmgt@permobil.com. 

We apologise for any inconvenience this may cause you and thank you in advance for assistance in implementing this correction.