Recall Z-2052-2023 ยท IOL Treadmill, Powered
Full Vision Inc
TRACKMASTER, TREADMILL TMX428 110V, MODEL NUMBER 317-07926
| Date | Jun 30, 2023 (initiated May 12, 2023) |
| Status | Open, Classified |
| Reason | Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. |
| Root cause | Other |
| Action | Trackmaster issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees beginning on 05/12/2023 by letter. The notice explained the problem and the risk during use, and requested the following: Immediate Actions to be taken by Customer/User: These steps are the recommendation of the Manufacturer to prevent injury and allow use of the device. Step 1: Instruct patient to straddle the belt and hold on to the handrails during initialization of the treadmill before starting the test Step 2: Send start/run command to the treadmill with patient still straddling the belt, wait 30 seconds to |
| Quantity | 565 units |
| Distribution | USA (Nationwide), Australia, Bahrain, Canada, Chile, Colombia, Costa Rica, Dominican Republic, FINLAND, Guatemala, HONG KONG, India, Indonesia, Israel, Mexico, NEW ZEALAND, Nicaragua, Panama, PARAQUAY, Peru, Philippines, Saudi Arabia, Singapore, SOUTH KOREA, Thailand, Ukraine, United Arab Emirates, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.