TGA Recall Reference Number: RC-2023-RN-00473-1
PushTracker E2 & E3 utilised with SmartDrive MX2+ Power Assist Device
ARTG 202708

Permobil Australia, following consultation with the Therapeutic Goods Administration, is supporting a medical device field correction of the PushTracker E2 and E3 component utilised with the SmartDrive MX2+ Power Assist Device. Impacted products were manufactured between May 06, 2019 through February 10, 2023.

The PushTracker E2 and E3 is a wearable watch that communicates with a SmartDrive Power Assist Device via the SmartDrive MX2+ Application. Through design and development activities, Max Mobility has identified a software issue with the SmartDrive MX2+ Application operating on Android WearOS. When multiple processes are running on the watch’s Central Processing Unit (CPU), the application may fail unexpectedly. If this happens, the motor on the power assist device continues to run and the user may not be able to stop the device using tap gestures.

The software has been corrected in SmartDrive MX2+ Version 1.1.00 and is now available on the Google Play Store.

How to determine if your software is up to date:

Option 1 – Determine if you are affected based on software version:

Depending on the home screen layout of the SmartDrive MX2+ App for PushTrackers E2 and E3, you should be able to easily identify if your PushTracker is up to date (version 1.1.00). If you have the user interface shown on the left, you are affected and will need to update your software.

Option 2 – Search for your watch by serial number:

A list of affected serial numbers can be found by following the link.

Your E2 or E3 PushTracker Serial Number can be found by following the steps below:

If you have purchased one or more of the impacted units, you will need to update your software to SmartDrive MX2+ Version 1.1.00 by following the instructions provided in the field action portal.

Link to field action portal: https://hub.permobil.com/en-au/smartdrive-voluntary-field-action

You will need to use the password SmartDrivePT2023 to access the survey.

1) Once you enter the portal, you will be asked to enter your contact information, select if you are a provider or end user and acknowledge that you have read and understood the Urgent Product Defect Correction letter. If you have not received a letter from your provider, please review the generic customer letter here. 

2) After acknowledgment, instructions to update your software will be provided.

3) Once the update has been completed, you will be asked to verify the correction by confirming version 1.1.00 is shown in the ‘About’ menu of your software.

If assistance is needed during the software update process, the portal will provide you with access to the Permobil Australia customer support team.

While a user is waiting for the correction, the following actions can be taken immediately to reduce the likelihood of the hazardous situation:

• Discontinue using the PushTracker E2 or E3 and utilise a wired controller (SwitchControl Buttons or SpeedControl Dial) or other wearable controllers (compatible Apple Watch or Samsung Galaxy Watch).
• If you are running multiple applications and experiencing any slowdown with the SmartDrive MX2+ application, close other applications.
• Follow the Instructions for Use and wear the PushTracker snug on your wrist.

If you have any questions, please contact Permobil Australia at 1300 845 483 or quality.au@permobil.com.

Max Mobility considers end user safety and customer satisfaction our top priorities. We apologise for any inconvenience this may cause you and thank you in advance for assistance in implementing this correction.