Recall Record

Newton, KS, United States

Full Vision Inc recalls

2 recalls recorded since 2018, most recently on 12 May 2023. 2 are listed as ongoing. Status and classification are as published by the FDA.

Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
12 May 2023
Reason
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
Distribution
USA (Nationwide), Australia, Bahrain, Canada, Chile, Colombia, Costa Rica, Dominican Republic, FINLAND, Guatemala, HONG KONG, India, Indonesia, Israel, Mexico, NEW ZEALAND, Nicaragua, Panama, PARAQUAY, Peru, Philippines, Saudi Arabia, Singapore, SOUTH KOREA, Thailand, Ukraine, United Arab Emirates,
Initiated
Voluntary: Firm initiated
Recall numbers
Z-2058-2023, Z-2055-2023, Z-2052-2023, Z-2057-2023, Z-2056-2023, Z-2053-2023, Z-2054-2023

Ongoing Class II Medical devices

Recall started
31 August 2022
Reason
This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnetic Safety Tether, that when the magnet is pulled loose as during a fall, the treadmill may fail to stop.
Distribution
Wi, GA, NY, Mexico
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0367-2023, Z-0365-2023, Z-0368-2023, Z-0370-2023, Z-0369-2023, Z-0366-2023, Z-0364-2023

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.