The Recall Desk
HighFDA (Devices)·Z-0369-2023·Announced 2022-12-14

Treadmill Magnetic Safety Tether Circuit May Fail During Falls

Full Vision Inc. is recalling 165 TrackMaster treadmills due to a circuit defect in the magnetic safety tether that may prevent the equipment from stopping when a user falls.

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 recall of a medical device with a documented functional defect in the circuit controlling the magnetic safety tether. The hazard creates a risk of injury if the safety system fails to stop the equipment during a fall. No injuries or deaths are reported in the source material. Per the rubric, this meets the criterion for 'High' severity: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Full Vision Inc. is recalling 165 TrackMaster treadmills (Model #317-07927GE, 220V). The magnetic safety tether system on these units is designed to stop the treadmill when a user falls and the magnet detaches.

A rare malfunction in the circuit board controlling the safety tether has been identified. Under specific conditions, this circuit can enter a latch-up state where the electrical circuit becomes stuck. When this occurs and the magnet is pulled loose during a fall, the treadmill may fail to stop.

The affected units have UDI/DI 00860176000675 and specific serial numbers ranging from GEDC-6608 through GEDC-6836. The treadmills were distributed in Wisconsin, Georgia, New York, and Mexico.

This recall addresses a potential hazard where the safety system may not function as intended during a fall, creating a risk of injury.

The recalled product

Product
FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST2 220V, Model #317-07927GE
Manufacturer
Full Vision Inc
Category
Medical Device — Exercise Equipment
Hazard
Affected units
165

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 00860176000675
  • Serial Numbers: GEDC-6608
  • GEDC-6609
  • GEDC-6610
  • GEDC-6611
  • GEDC-6612
  • GEDC-6613
  • GEDC-6614
  • GEDC-6615
  • GEDC-6616
  • GEDC-6617
  • GEDC-6618
  • GEDC-6619
  • GEDC-6620
  • GEDC-6621
  • GEDC-6622
  • GEDC-6623
  • GEDC-6624
  • GEDC-6625
  • GEDC-6626

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 →

Related recalls

Same manufacturer · Full Vision Inc

See all →