FDA recall record

Full Vision TRACKMASTER, TREADMILL GE T2100-ST2 220V CHINA, MODEL NUMBER 317-07927GE CHINA recall — FDA Z-2058-2023

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

Class IIclassification
Z-2058-2023official record ID
Jul 12, 2023report date

Recall record at a glance

Official recordZ-2058-2023
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmFull Vision Inc.
Report dateJul 12, 2023
Recall initiation dateMay 12, 2023
Quantity95 units
LocationNewton, KS, United States

Official product description

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

Why the product was recalled

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

Distribution information

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, United Kingdom, Uruguay

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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