Z-0365-2023Class II

FULL VISION INC. TRACKMASTER,TREADMILL TMX428 220V, Model #317-07927

Name: Z-0365-2023 FULL VISION INC. TRACKMASTER,TREADMILL TMX428 220V, Model #317-07927
Creator: Full Vision Inc
Published: 2022-08-31
License: https://open.fda.gov/license/

Full Vision Inc / initiated 2022-08-31 / Open, Classified

FDA source

Full Vision Inc began a recall of FULL VISION INC. TRACKMASTER,TREADMILL TMX428 220V, Model #317-07927 on 2022-08-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0365-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-31
Posted: 2022-12-03
Recalling firm: Full Vision Inc
Product: FULL VISION INC. TRACKMASTER,TREADMILL TMX428 220V, Model #317-07927
Product code: IOL Treadmill, Powered
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.
FDA root cause: Other
Action: 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."
Quantity in commerce: 38 units
Distribution: Wi, GA, NY, Mexico
Product codes and lots: 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, FVDC-7657, FVDC-7658, FVDC-7659, FVDC-7660, FVDC-7661, FVDC-7662, FVDC-7663, FVDC-7664, FVDC-7665, FVDC-7707, FVDC-7708, FVDC-7709, FVDC-7710, FVDC-7711, FVDC-7712, FVDC-7713, FVDC-7714, FVDC-7715, FVDC-7716

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0365-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0364-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-02
Z-0365-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-02
Z-0366-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-02
Z-0367-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-02
Z-0368-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-02
Z-0369-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-02
Z-0370-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-02

Product code IOL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)