PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX...
FDA Recall #Z-2005-2023 — Class II — May 10, 2023
Product Description
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
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.
Recalling Firm
Permobil — Lebanon, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
6,196 units
Distribution
Worldwide distribution.
Code Information
All units with software versions 1.0.00 to 1.0.04
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated