The Recall Desk
HighFDA (Devices)·Z-2054-2023·Announced 2023-07-12

TrackMaster Treadmill Recalled for Drive PCB Malfunction Risk

Full Vision Inc. is recalling 39 TrackMaster treadmills with a drive PCB malfunction that can cause unexpected stopping, reversal, or acceleration.

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: This is an FDA Class II medical device recall involving a malfunction that can cause unexpected acceleration and stopping in exercise equipment. As no injuries or hospitalizations are reported in the source material, this represents a potential hazard without documented harm, warranting a severity score of 3 (High) per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Full Vision Inc. is recalling 39 TrackMaster treadmill units (model TMX428CP 110V, model number 317-07928) due to a malfunction in the drive PCB (printed circuit board).

The drive PCB can misread electrical signals. When this occurs, the treadmill may stop or reverse unexpectedly, then accelerate forward. These malfunctions are the basis for this recall.

The affected treadmills have been distributed nationwide in the USA and internationally to 28 additional countries and territories. The recall involves 39 specific units, each identifiable by its unique serial number (all beginning with 'FVDC').

The recalled product

Product
TRACKMASTER, TREADMILL TMX428CP 110V, MODEL NUMBER 317-07928
Manufacturer
Full Vision Inc
Hazard
  • malfunction
  • unexpected-acceleration
  • sudden-stop

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 00860176000620
  • Serial Numbers: FVDC-7644
  • FVDC-7645
  • FVDC-7646
  • FVDC-7686
  • FVDC-7786
  • FVDC-7888
  • FVDC-7927
  • FVDC-8192
  • FVDC-8255
  • FVDC-8310
  • FVDC-8316
  • FVDC-8317
  • FVDC-8318
  • FVDC-8319
  • FVDC-8320
  • FVDC-8321
  • FVDC-8322
  • FVDC-8323
  • FVDC-8324

Distribution

Distributed nationwide across the United States.