Recall Z-2005-2023
Permobil · initiated May 10, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: All units with software versions 1.0.00 to 1.0.04
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.
FDA-determined 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.
Details
- Recall number
- Z-2005-2023
- Initiated
- May 10, 2023
- Posted by FDA
- June 26, 2023
- Product code
- ITI – Wheelchair, Powered
- Quantity
- 6,196 units
- Distribution
- Worldwide distribution.
- Recalling firm
- Permobil, Lebanon, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2004-2023 Class II | PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part…When multiple processes are running on the watch's Central Processing Unit (CPU), the application may fail… | 05/10/2023Open, Classified |