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U.S. Department of Health and Human Services

Class 2 Device Recall Quantum Rehab

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 Class 2 Device Recall Quantum Rehabsee related information
Date Initiated by FirmJune 25, 2026
Date PostedJuly 31, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2849-2026
Recall Event ID 99286
510(K)NumberK143383 
Product Classification Wheelchair, powered - Product Code ITI
ProductBrand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Catalog Number: Q6 Edge 3 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Code Information Lot Code: Q6 Edge 3 0060650920015*8 K143383 D246699 41875 ITI
FEI Number 3005068474
Recalling Firm/
Manufacturer
Pride Mobility Products Corp.
401 York Ave
Duryea PA 18642-2025
For Additional Information ContactKelly Livingston
1-800-8008586 Ext. 1381
Manufacturer Reason
for Recall
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
FDA Determined
Cause 2
Under Investigation by firm
ActionFirm notified dealers and consumers via mailed letters on June 25, 2026. Dealers were instructed to locate affected units and inform consumers of the required software update. Dealers should schedule service appointments with affected consumers. Systems should be updated to Q-Logic software version 2.0.13 or later. The update must be completed following a system power cycle. Consumers were instructed to disable the "Remind Me Later" feature immediately. Consumers should contact their dealer to schedule an appointment for software update.
Quantity in Commerce1102
DistributionWorldwide - US Nationwide distribution including in the states of AZ, NJ, PA, OK, CO, IN, AR, KS, CT, MD, WI, TX, FL, WA, NY, MO, LA, UT, OR, VA, RI, CA, TN, MN, KY, NV, GA, WV, IL, OH, SC, WY, AL, MI, ME, NC, SD, DE, MA, NE, ND, IA, NH, NM, MT, ID, MS, DC, AK and the countries of Canada and Australia.
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 = ITI
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