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Recall Observatory FDA recall evidence

Device product

iBOT PMD with software version 01.05.24. Personal Mobility Device.

Z-1965-2025

April 24, 2025

Class II

Product summary

Firm
Mobius Mobility LLC
Event
Event 96834
Status
Ongoing
Classification
Class II
Quantity
442 units
Official record key
device-enforcement:Z-1965-2025

Official wording

Reason: Software issue that could potentially lead to the device tipping over from Balance Mode.

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.

Distribution pattern: US Nationwide distribution in the states of CA, CO, FL, GA, IN, NC, NJ, OH, PR, RI, TN, TX & VA.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software issue