FDA Recall: Software issue could lead to the device tipping over from Balance Mode.

Company: Mobius Mobility LLC
Date of Enforcement Report: 6/12/2025
Class: II

PRODUCT

iBOT PMD with software version 01.05.24. Personal Mobility Device.

Recall Number:

Z-1965-2025

REASON:

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

RECALLING FIRM/MANUFACTURER:

Mobius Mobility LLC

VOLUME:

442 units

DISTRIBUTION:

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

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

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Software Verification

IEC 62366 Usability Process and Documentation

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15148 Springview St.
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USA
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Partners located in the US (CA, FL, MA, MN, TX) and Canada.