Z-1965-2025 Class II Ongoing
FDA device recall Z-1965-2025 was initiated by Mobius Mobility LLC on April 24, 2025 and is designated Class II. Reason for recall: Software issue that could potentially lead to the device tipping over from Balance Mode. The recall status is ongoing. Affected quantity: 442 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 18, 2025
- Initiation Date
- April 24, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 442 units
Product Description
iBOT PMD with software version 01.05.24. Personal Mobility Device.
Reason for Recall
Software issue that could potentially lead to the device tipping over from Balance Mode.
Distribution Pattern
US Nationwide distribution in the states of CA, CO, FL, GA, IN, NC, NJ, OH, PR, RI, TN, TX & VA.
Code Information
Software Version 01.05.24; UDI (01) 00857584008010 (21) 0001108, (01) 00857584008010 (21) 0001110, (01) 00857584008010 (21) 0001121, (01) 00857584008010 (21) 0001123, (01) 00857584008010 (21) 0001128, (01) 00857584008010 (21) 0001136, (01) 00857584008010 (21) 0001137, (01) 00857584008010 (21) 0001422, (01) 00857584008010 (21) 0001438, (01) 00857584008010 (21) 0001496, (01) 00857584008010 (21) 0001505, (01) 00857584008010 (21) 0001508, (01) 00857584008010 (21) 0001516, (01) 00857584008010 (21) 0001517, (01) 00857584008010 (21) 0001519; Serial No. 0001108, 0001422, 0001438, 0001496, 0001505, 0001508, 0001516, 0001517, 0001519, 0001110, 0001121, 0001123, 0001128, 0001136, 0001137.