iBOT PMD with software version 01.05.24. Personal Mobility Device.
Summary
The FDA issued a Class II for iBOT PMD with software version 01.05.24. Personal Mobility Device. by Mobius Mobility LLC. Reason: Software issue that could potentially lead to the device tipping over from Balance Mode..
Details
Source
Device Recall
External ID
Z-1965-2025
Action Date
2025-06-18
Status
Ongoing
Category
device
Product Description
iBOT PMD with software version 01.05.24. Personal Mobility Device.
Lot/Code Info: 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.
Quantity Affected: 442 units
Reason for Recall
Software issue that could potentially lead to the device tipping over from Balance Mode.
Distribution
US Nationwide distribution in the states of CA, CO, FL, GA, IN, NC, NJ, OH, PR, RI, TN, TX & VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-24
Company
Manchester, NH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mobius Mobility LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mobius Mobility LLC have FDA actions?
This is the only FDA action we have on record for Mobius Mobility LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1965-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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