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Recall Observatory FDA recall evidence

Device product

FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 220V, Model #317-07929

Z-0367-2023

August 31, 2022

Class II

Product summary

Firm
Full Vision Inc
Event
Event 90995
Status
Ongoing
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-0367-2023

Official wording

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 information: UDI/DI 00860176000637, Serial Numbers: FVDC-7641, FVDC-7642, FVDC-7643

Distribution pattern: Wi, GA, NY, Mexico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.