Recall Z-0370-2023
Full Vision Inc · initiated August 31, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST2 220V, Model #317-07927GE CHINA
Codes / lots: UDI/DI 00860176000675, Serial Numbers: GEDC-6765, GEDC-6766, GEDC-6767, GEDC-6768, GEDC-6849, GEDC-6850, GEDC-6851, GEDC-6852
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-determined cause: Other
Action taken
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."
Details
- Recall number
- Z-0370-2023
- Initiated
- August 31, 2022
- Posted by FDA
- December 3, 2022
- Product code
- IOL – Treadmill, Powered
- Quantity
- 8 units
- Distribution
- Wi, GA, NY, Mexico
- Recalling firm
- Full Vision Inc, Newton, KS
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0364-2023 Class II | FULL VISION INC. TRACKMASTER, TREADMILL TMX428 110V, Model #317-07926This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a… | 08/31/2022Open, Classified |
| Z-0365-2023 Class II | FULL VISION INC. TRACKMASTER,TREADMILL TMX428 220V, Model #317-07927This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a… | 08/31/2022Open, Classified |
| Z-0366-2023 Class II | FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 110V, Model #317-07928This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a… | 08/31/2022Open, Classified |
| Z-0367-2023 Class II | FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 220V, Model #317-07929This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a… | 08/31/2022Open, Classified |
| Z-0368-2023 Class II | FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST1 110V, Model #317-07926GEThis has been identified a rare occurrence, under a specific scenario, where the circuit is found in a… | 08/31/2022Open, Classified |
| Z-0369-2023 Class II | FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST2 220V, Model #317-07927GEThis has been identified a rare occurrence, under a specific scenario, where the circuit is found in a… | 08/31/2022Open, Classified |