iBOT PMD with software version 01.05.24. Personal Mobility Device.
FDA device recall Z-1965-2025 · posted 2025-06-12 · Open, Classified
Recall details
- Recalling firm
- Mobius Mobility LLC
- Reason for recall
- Software issue that could potentially lead to the device tipping over from Balance Mode.
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- IMK
- Quantity affected
- 442 units
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, GA, IN, NC, NJ, OH, PR, RI, TN, TX & VA.
- Date initiated
- 2025-04-24
- Date posted
- 2025-06-12
- Location
- Manchester, NH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| iBOT® PMD (K243442) | Mobius Mobility | 2025-01-30 |