FDA Medical Device Recalls (openFDA)
Full Vision Inc: FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 220V, Model #317-07929
- Recall number
- Z-0367-2023
- Recalling firm
- Full Vision Inc
- Product
- FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 220V, Model #317-07929
- Status
- Open, Classified
- Initiated
- 2022-08-31
- Posted
- 2022-12-03
- Terminated
- not on file
- 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 safety function of the Magnetic Safety Tether, that when the magnet is pulled loose as during a fall, the treadmill may fail to stop.
- 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
- 3 units
- Distribution
- Wi, GA, NY, Mexico
- Lot, serial or model codes
- UDI/DI 00860176000637, Serial Numbers: FVDC-7641, FVDC-7642, FVDC-7643
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IOL
- Firm FEI
- 3001040337
- Firm city
- Newton
- Firm state
- KS
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28