FDA Enforcement
Class II
Ongoing
FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST2 220V, Model #317-07927GE CHINA
Recall: Z-0370-2023
·
Reported December 14, 2022
Enforcement
- Recall Number
- Z-0370-2023
- Event ID
- 90995
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Full Vision Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 14, 2022
- Initiation Date
- August 31, 2022
- Classification Date
- December 2, 2022
- Address
- 3017 Full Vision Dr, N/A, Newton, KS, 67114-9750, United States
Description
FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST2 220V, Model #317-07927GE CHINA
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.
Code Info
UDI/DI 00860176000675, Serial Numbers: GEDC-6765, GEDC-6766, GEDC-6767, GEDC-6768, GEDC-6849, GEDC-6850, GEDC-6851, GEDC-6852
Distribution
Wi, GA, NY, Mexico
Quantity
8 units