PushTracker E2 (Permobil) – CPU Processing Risk (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-33P, MX2-33PK, MX2-33S, MX2-150, MX2-167, MX2-32D); a wearable watch that communicates with a SmartDrive Power Assist Device via the SmartDrive MX2+ Application
Brand
Permobil
Lot Codes / Batch Numbers
All units with software versions 1.0.00 to 1.0.04
Products Sold
All units with software versions 1.0.00 to 1.0.04
Permobil is recalling PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-3 due to When multiple processes are running on the watch's Central Processing Unit (CPU), the application may fail unexpectedly. If this happens, the motor on. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Permobil began notifying customers via in-person and through letters on 05/10/2023. Customers were instructed to examine their device and update their software to SmartDrive MX2+ Version 1.1.00, to acknowledge the update was conducted and the notification letter was understood through the field action portal, notify customers if the affected devices were further distributed. They were also instructed to discontinue using the affected device while waiting for the correction.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026