Recall Z-0369-2023 ยท IOL Treadmill, Powered
Full Vision Inc
FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST2 220V, Model #317-07927GE
| Date | Dec 3, 2022 (initiated Aug 31, 2022) |
| Status | Open, Classified |
| 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. Sta |
| Quantity | 165 units |
| Distribution | Wi, GA, NY, Mexico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.