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U.S. Department of Health and Human Services

Class 2 Device Recall iBOT PMD

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 Class 2 Device Recall iBOT PMDsee related information
Date Initiated by FirmApril 24, 2025
Date PostedJune 12, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1965-2025
Recall Event ID 96834
510(K)NumberK243442 
Product Classification Wheelchair, stair climbing - Product Code IMK
ProductiBOT PMD with software version 01.05.24. Personal Mobility Device.
Code Information 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.
FEI Number 3014522447
Recalling Firm/
Manufacturer		 Mobius Mobility LLC
540 N Commercial St Ste 310
Manchester NH 03101-1146
For Additional Information ContactJill Kolczynski
833-346-4268 Ext. 6585
Manufacturer Reason
for Recall		Software issue that could potentially lead to the device tipping over from Balance Mode.
FDA Determined
Cause 2		Software design
ActionConsignees 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 Commerce442 units
DistributionUS Nationwide distribution in the states of CA, CO, FL, GA, IN, NC, NJ, OH, PR, RI, TN, TX & VA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = IMK
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