iBOT PMD with software version 01.05.24. Personal Mobility Device.
This recall is currently active, issued June 12, 2025. It was issued by Mobius Mobility Llc.
- Company
- Mobius Mobility Llc
- Recall Initiated
- April 24, 2025
- Posted
- June 12, 2025
- Recall Number
- Z-1965-2025
- Quantity
- 442 units
- Firm Location
- Manchester, NH
- Official Source
- View on FDA website ↗
Reason for Recall
Software issue that could potentially lead to the device tipping over from Balance Mode.
Distribution
US Nationwide distribution in the states of CA, CO, FL, GA, IN, NC, NJ, OH, PR, RI, TN, TX & VA.
Lot / Code Info
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.
Root Cause
Software design
Action Taken
Consignees were initially contacted via telephone on 4/24/25 to notify them of this software issue. An URGENT MEDICAL DEVICE CORRECTION NOTICE dated 5/5/25 was emailed to consignees to notify them of the recall and instructing them that the firm is developing a software correction. Once Mobius Mobility has obtained a correction they will reach out to consignees to schedule a time to update affected devices. Consignees with any questions can email service @mobiusmobility.com or call 833-346-4268x2.