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Trackmaster recallZ-0364-2023 · Full Vision Inc · initiated Aug 31, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Full Vision Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Other

What the company is doing

The firm began sending URGENT MEDICAL DEVICE CORRECTION notices its consignees by email beginning 09/13/2022. The distributors were provided with a letter to distribute to their customers (end users) The notice explained the issue, risk to health, and requested the following actions be taken: "Actions to be taken by the Customer/User: A simple test can be performed to determine if the unit has the incorrect component installed on the PCB Assembly. The user should turn the device on. Then cycle the power with the power switch by turning it off, waiting 5 seconds, then turn it back on. Start the belt at 2 mph and pull the Magnetic Tether. If the assembly has the incorrect component the device should fail to stop. If the assembly has the correct component the device should stop. The assemblies that fail to stop should be replaced with the c-clip style safety tethers, provided by Full Vision to the distributors and end users. To continue using the treadmill with the Magnetic Tether assemblies until they can be replaced, you can prevent this condition from occurring by cycling the power for 30 seconds before turning the device back on. Product Correction: Full Vision has scrapped all the non-conforming components (Magnetic Safety Tether and PCB Board Assembly) from the inventory. All nonconforming components will be replaced."

Recall details

Recall number
Z-0364-2023
Status
Open, Classified
Initiated by the company
Aug 31, 2022
Posted by the FDA
Dec 3, 2022
Recalling firm
Full Vision Inc
Quantity
106 units
Product code
IOL
Distribution
Wi, GA, NY, Mexico

Product description

FULL VISION INC. TRACKMASTER, TREADMILL TMX428 110V, Model #317-07926

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

UDI/DI 00860176000606, Serial Numbers: FVDC-7585, FVDC-7586, FVDC-7587, FVDC-7588, FVDC-7589, FVDC-7590, FVDC-7591, FVDC-7592, FVDC-7593, FVDC-7594, FVDC-7595, FVDC-7596, FVDC-7597, FVDC-7598, FVDC-7599, FVDC-7600, FVDC-7601, FVDC-7602, FVDC-7603, FVDC-7604, FVDC-7605, FVDC-7606, FVDC-7607, FVDC-7608, FVDC-7609, FVDC-7610, FVDC-7611, FVDC-7612, FVDC-7613, FVDC-7614, FVDC-7615, FVDC-7616, FVDC-7617, FVDC-7618, FVDC-7619, FVDC-7620, FVDC-7621, FVDC-7622, FVDC-7623, FVDC-7624, FVDC-7625, FVDC-7626, FVDC-7627, FVDC-7628, FVDC-7629, FVDC-7640, FVDC-7666, FVDC-7667, FVDC-7668, FVDC-7669, FVDC-7670, FVDC-7671, FVDC-7672, FVDC-7673, FVDC-7674, FVDC-7675, FVDC-7676, FVDC-7677, FVDC-7678, FVDC-7679, FVDC-7680, FVDC-7681, FVDC-7682, FVDC-7683, FVDC-7684, FVDC-7685, FVDC-7687, FVDC-7688, FVDC-7689, FVDC-7690, FVDC-7691, FVDC-7692, FVDC-7693, FVDC-7694, FVDC-7695, FVDC-7696, FVDC-7697, FVDC-7698, FVDC-7699, FVDC-7700, FVDC-7701, FVDC-7702, FVDC-7703, FVDC-7704, FVDC-7705, FVDC-7706, FVDC-7717, FVDC-7719, FVDC-7720, FVDC-7721, FVDC-7722, FVDC-7723, FVDC-7724, FVDC-7725, FVDC-7726, FVDC-7727, FVDC-7728, FVDC-7729, FVDC-7730, FVDC-7731, FVDC-7732, FVDC-7733, FVDC-7734, FVDC-7735, FVDC-7736, FVDC-7737

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 90995).

Sources and updates

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