Z-1965-2025Class II

iBOT PMD with software version 01.05.24. Personal Mobility Device

Name: Z-1965-2025 iBOT PMD with software version 01.05.24. Personal Mobility Device
Creator: Mobius Mobility LLC
Published: 2025-04-24
License: https://open.fda.gov/license/

Mobius Mobility LLC / initiated 2025-04-24 / Open, Classified / root cause: software

FDA source

Mobius Mobility LLC began a recall of iBOT PMD with software version 01.05.24. Personal Mobility Device on 2025-04-24. FDA classified it as Class II and gives the reason as "Software issue that could potentially lead to the device tipping over from Balance Mode". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1965-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-24
Posted: 2025-06-12
Recalling firm: Mobius Mobility LLC
Product: iBOT PMD with software version 01.05.24. Personal Mobility Device.
Product code: IMK Wheelchair, Stair Climbing
Reason for recall: Software issue that could potentially lead to the device tipping over from Balance Mode.
Root cause tag: software
FDA 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 in commerce: 442 units
Distribution: US Nationwide distribution in the states of CA, CO, FL, GA, IN, NC, NJ, OH, PR, RI, TN, TX & VA.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1965-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1965-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-12

Product code IMK

K243442Class IIiBOT® PMDMobius Mobility / cleared 2025-01-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)