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
This recall is currently active, issued June 26, 2023. It was issued by Permobil.
- Company
- Permobil
- Recall Initiated
- May 10, 2023
- Posted
- June 26, 2023
- Recall Number
- Z-2004-2023
- Quantity
- 18,905 units
- Firm Location
- Lebanon, TN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide distribution.
Lot / Code Info
All units with software versions 1.0.00 to 1.0.04
Root Cause
Software design
Action Taken
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.