Recall Z-0364-2023— Full Vision Inc
Class II · Ongoing
Class II FDA medical device recall by Full Vision Inc, initiated 2022-08-31. FDA's recall record names no specific 510(k) clearance for this event. Product: FULL VISION INC. TRACKMASTER, TREADMILL TMX428 110V, Model #317-07926. 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..
- Recalling firm
- Full Vision Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-08-31
- Firm location
- Newton, KS, United States
Product description
FULL VISION INC. TRACKMASTER, TREADMILL TMX428 110V, Model #317-07926
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.