medical Class II Updated 2023-07-05

Permobil recalls PushTracker E3 component utilized with the SmartDrive MX2+ P

Recalled Product

PushTracker E3 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


Hazard / Issue

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.

Issued by

FDA

Distribution: Worldwide distribution.
Lot/Code Info: All units with software versions 1.0.00 to 1.0.04
View official government recall

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