FDA DeviceClass IINotable

FDA Recall: Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0

Date: 2026-08-12
Brand: Pride Mobility Products Corp.
Category: Medical Device
FDA Class: Class II

Description

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.

Hazard

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.

Remedy

1102

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