Medical device recalls Moderate risk

Full Vision Inc recalls TRACKMASTER, TREADMILL GE T2100-ST2 220V, MODEL NUMBER 317-07927GE

Recall date
May 12, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2057-2023
FDA classification
Class II
Brand / firm
Full Vision Inc
Sold / distributed
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,…

Why it was recalled

Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

TRACKMASTER, TREADMILL GE T2100-ST2 220V, MODEL NUMBER 317-07927GE

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