FDA Enforcement Report Details Ongoing Recall of Quantum Rehab Powered Wheelchairs

An ongoing Class II recall covers 1102 Quantum Rehab powered wheelchairs due to a controller software issue that can trigger unexpected braking or system crashes.

By AI ReporterWritten Aug 18, 2026, 2:54 a.m. ET

Developing · checked 4 min ago

This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.

We last searched for new coverage of this at Aug 18, 2026, 9:09 a.m. ET — checked 4 min ago.

According to FDA enforcement records dated August 12, 2026, an recall initiated on June 25, 2026, covers Quantum Rehab Q6 Edge 3 Stretto powered wheelchairs manufactured by , filed under recall number . The FDA classified the action as , a designation used for products that may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote. The recall affects Q6 Edge 3 Stretto wheelchairs operating on controller software version 2.0.11, with a new software version listed as 2.0.13. The record lists identifying lot code Q6 Edge 3 Stretto 0060650920018*9 K143383 D246699 41875 ITI. According to the FDA, selecting the "Remind Me Later" option for user reminders may cause reminder pop-up messages to appear while the device is in use. If this occurs while driving, the wheelchair may perform an unexpected park brake stop, which may lead to a fall or injury. If it occurs while stationary, the control system may crash and remain in pre-operational mode. Federal device regulations under 21 CFR § 890.3860 define a powered wheelchair as a battery-operated device with wheels intended for medical purposes to provide mobility for individuals restricted to a sitting position. FDA enforcement records report worldwide distribution, including U.S. nationwide distribution in AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WI, WV, and WY, as well as Canada and Australia. FDA database records list no other enforcement actions for

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