Recall Z-2056-2023
Full Vision Inc · initiated May 12, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
TRACKMASTER, TREADMILL GE T2100-ST1 110VV, MODEL NUMBER 317-07926GE
Codes / lots: UDI/DI 00860176000668, Serial Numbers: GEDC-6632, GEDC-6633, GEDC-6634, GEDC-6635, GEDC-6636, GEDC-6637, GEDC-6638, GEDC-6639, GEDC-6640, GEDC-6641, GEDC-6642, GEDC-6643, GEDC-6644, GEDC-6645, GEDC-6646, GEDC-6647, GEDC-6648, GEDC-6649, GEDC-6650, GEDC-6651, GEDC-6652, GEDC-6653, GEDC-6654, GEDC-6655, GEDC-6656, GEDC-6657, GEDC-6658, GEDC-6659, GEDC-6660, GEDC-6661, GEDC-6662, GEDC-6663, GEDC-6664, GEDC-6665, GEDC-6666, GEDC-6667, GEDC-6668, GEDC-6669, GEDC-6670, GEDC-6671, GEDC-6672, GEDC-6673, GEDC-6674, GEDC-6675, GEDC-6676, GEDC-6677, GEDC-6678, GEDC-6679, GEDC-6680, GEDC-6681, GEDC-6755, GEDC-6756, GEDC-6757, GEDC-6758, GEDC-6759, GEDC-6760, GEDC-6761, GEDC-6762, GEDC-6763, GEDC-6764, GEDC-6839, GEDC-6840, GEDC-6841, GEDC-6842, GEDC-6843, GEDC-6844, GEDC-6845, GEDC-6846, GEDC-6847, GEDC-6848, GEDC-7012, GEDC-7013, GEDC-7014, GEDC-7015, GEDC-7016, GEDC-7017, GEDC-7018, GEDC-7019, GEDC-7020, GEDC-7021, GEDC-7022, GEDC-7023, GEDC-7064, GEDC-7065, GEDC-7066, GEDC-7067, GEDC-7068, GEDC-7069, GEDC-7070, GEDC-7071, GEDC-7072, GEDC-7073, GEDC-7104, GEDC-7105, GEDC-7106, GEDC-7107, GEDC-7108, GEDC-7139, GEDC-7140, GEDC-7141, GEDC-7142, GEDC-7143, GEDC-7174, GEDC-7175, GEDC-7176…
Reason for recall
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
FDA-determined cause: Other
Action taken
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 ensure there is no uncommanded motion Step 3: Instruct patient to carefully step on the belt while holding on to the handrails, begin walking and continue with the test Step 4: Patients unable to perform steps 1-3 must not use the treadmill Step 5: Print Appendix B and attach to the treadmill until corrections are made and ensure it is visible to the clinician and user
Details
- Recall number
- Z-2056-2023
- Initiated
- May 12, 2023
- Posted by FDA
- June 30, 2023
- Product code
- IOL – Treadmill, Powered
- Quantity
- 264 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, United Kingdom, Uruguay
- Recalling firm
- Full Vision Inc, Newton, KS
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2052-2023 Class II | TRACKMASTER, TREADMILL TMX428 110V, MODEL NUMBER 317-07926Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. | 05/12/2023Open, Classified |
| Z-2053-2023 Class II | TRACKMASTER, TREADMILL TMX428 220V, MODEL NUMBER 317-07927Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. | 05/12/2023Open, Classified |
| Z-2054-2023 Class II | TRACKMASTER, TREADMILL TMX428CP 110V, MODEL NUMBER 317-07928Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. | 05/12/2023Open, Classified |
| Z-2055-2023 Class II | TRACKMASTER, TREADMILL TMX428CP 220V, MODEL NUMBER 317-07929Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. | 05/12/2023Open, Classified |
| Z-2057-2023 Class II | TRACKMASTER, TREADMILL GE T2100-ST2 220V, MODEL NUMBER 317-07927GETreadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. | 05/12/2023Open, Classified |
| Z-2058-2023 Class II | TRACKMASTER, TREADMILL GE T2100-ST2 220V CHINA, MODEL NUMBER 317-07927GE CHINATreadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. | 05/12/2023Open, Classified |