The Recall Desk
HighFDA (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.

What this means for you

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
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 →

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