Summary
The FDA issued a Class II for FULL VISION INC. TRACKMASTER, TREADMILL TMX428 110V, Model #317-07926 by Full Vision Inc. Reason: 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.
Details
Source
Device Recall
External ID
Z-0364-2023
Action Date
2022-12-14
Status
Ongoing
Category
device
Product Description
FULL VISION INC. TRACKMASTER, TREADMILL TMX428 110V, Model #317-07926
Lot/Code Info: 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
Quantity Affected: 106 units
Reason for Recall
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.
Distribution
Wi, GA, NY, Mexico
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-31
Company
Newton, KS
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Full Vision Inc has 14 FDA actions in our database, including 14 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Full Vision Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Full Vision Inc have FDA actions?
Full Vision Inc has 14 FDA actions in our database, including 14 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0364-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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