Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

iBOT PMD with software version 01.05.24. Personal Mobility Device.

FDA Recall Z-1965-2025 · Posted 2025-06-12

Recalling FirmMobius Mobility LLC
Recall StatusOpen, Classified
Product CodeIMK
Date Initiated2025-04-24
Product Quantity442 units

Reason for Recall

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

Firm Action

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.

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K243442iBOT® PMDMobius Mobility · 2025-01-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑