PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK
FDA device recall Z-2004-2023 · posted 2023-06-26 · Open, Classified
Recall details
- Recalling firm
- Permobil
- 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.
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- ITI
- Quantity affected
- 18,905 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2023-05-10
- Date posted
- 2023-06-26
- Location
- Lebanon, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SmartDrive Wheelchair Power Assist (K151199) | Max Mobility, LLC | 2015-07-30 |