Agency classClass IIOur severity:High FDA (Devices)·Z-0365-2023·Announced 2022-12-14

Full Vision TrackMaster Treadmill Emergency Stop Failure Recall

Full Vision Inc. is recalling 38 TrackMaster TMX428 220V treadmills due to a rare circuit failure that may prevent the magnetic safety tether from stopping the machine during a fall.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with safety-critical failure (magnetic emergency stop system) that poses a direct risk of serious injury if activated during use. No illnesses or injuries have been reported to date. Classified as High severity per criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Full Vision Inc. is recalling 38 units of its TrackMaster TMX428 220V treadmill (Model #317-07927). The affected treadmills can be identified by their serial numbers: FVDC-7630, FVDC-7631, FVDC-7633, FVDC-7634, FVDC-7635, FVDC-7636, FVDC-7637, FVDC-7638, FVDC-7639, FVDC-7647 through FVDC-7716 (UDI/DI 00860176000613).

The circuit board controlling the magnetic safety tether may enter a latch-up condition under specific circumstances. If the magnet is pulled loose during a fall when this circuit failure occurs, the treadmill may fail to stop, creating a risk of serious injury to the user.

These treadmills were distributed to locations in Wisconsin, Georgia, New York, and Mexico.

Users of affected treadmills should stop using them immediately and contact Full Vision Inc. for repair or replacement instructions.

The recalled product

Product: FULL VISION INC. TRACKMASTER,TREADMILL TMX428 220V, Model #317-07927
Manufacturer: Full Vision Inc
Category: Medical Device — Treadmill / Exercise Equipment
Hazard: brake-failure
circuit-failure
Affected units: 38

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

UDI/DI 00860176000613
Serial Numbers: FVDC-7630
FVDC-7631
FVDC-7633
FVDC-7634
FVDC-7635
FVDC-7636
FVDC-7637
FVDC-7638
FVDC-7639
FVDC-7647
FVDC-7648
FVDC-7649
FVDC-7650
FVDC-7651
FVDC-7652
FVDC-7653
FVDC-7654
FVDC-7655
FVDC-7656

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 7 recalled by Full Vision Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · Full Vision Inc

See all →

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TrackMaster Treadmill Recalled for Drive PCB Malfunction Risk
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TrackMaster GE Treadmill Recall Due to Drive Circuit Board Malfunction
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Same hazard · brake failure