Z-2005-2023 Class II Ongoing
FDA device recall Z-2005-2023 was initiated by Permobil on May 10, 2023 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 6,196 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 5, 2023
- Initiation Date
- May 10, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,196 units
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.
Distribution Pattern
Worldwide distribution.
Code Information
All units with software versions 1.0.00 to 1.0.04