FDAFDA · Food and drugs·Recall number Z-2004-2023
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
Published July 5, 2023 · Recall initiated: May 10, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Permobil
- Distributor
- Worldwide distribution.
- Lot
- All units with software versions 1.0.00 to 1.0.04
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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