Recall Z-1965-2025 · IMK Wheelchair, Stair Climbing
Mobius Mobility LLC
iBOT PMD with software version 01.05.24. Personal Mobility Device.
| Date | Jun 12, 2025 (initiated Apr 24, 2025) |
| Status | Open, Classified |
| Reason | Software issue that could potentially lead to the device tipping over from Balance Mode. |
| Root cause | Software design |
| 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. |
| Quantity | 442 units |
| Distribution | US Nationwide distribution in the states of CA, CO, FL, GA, IN, NC, NJ, OH, PR, RI, TN, TX & VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K243442 | iBOT® PMD Mobius Mobility, Jan 30, 2025 |