Quantum Rehab Q6 Edge 3 Stretto recalled by Pride Mobility Products

Timeline

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Stretto Model/Catalog Number: Q6 Edge 3 Stretto Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

Where it was distributed

Worldwide - 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.

Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland