iBOT PMD Personal Mobility Device Software Update Recall
Mobius Mobility LLC is recalling 442 units of the iBOT PMD (Personal Mobility Device) with software version 01.05.24 due to a software issue that could cause the device to tip over during Balance Mode operation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a risk-of-harm medical device defect (potential tipping hazard that could cause injury). The source text does not report any illnesses or injuries to date, but the risk of harm from a balance-related device failure in a mobility aid is inherent and classifies as High per the rubric.
Plain-English summary
Mobius Mobility LLC is recalling 442 units of the iBOT PMD (Personal Mobility Device) with software version 01.05.24. The device is affected by a software issue that could potentially lead to the device tipping over when in Balance Mode.
The recalled devices were distributed nationwide in California, Colorado, Florida, Georgia, Indiana, North Carolina, New Jersey, Ohio, Puerto Rico, Rhode Island, Tennessee, Texas, and Virginia. The affected units carry specific serial numbers and UDI codes as identified by the manufacturer.
Consumers who own an affected iBOT PMD should stop using the device in Balance Mode and contact Mobius Mobility LLC for further instructions regarding a software update or replacement.
The recalled product
- Product
- iBOT PMD with software version 01.05.24. Personal Mobility Device.
- Manufacturer
- Mobius Mobility LLC
- Affected units
- 442
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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Same hazard · tipping hazard
See all →- High
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