TRACKMASTER, TREADMILL TMX428 220V, MODEL NUMBER 317-07927

FDA device recall Z-2053-2023 · posted 2023-06-30 · Open, Classified

Recall details

Recalling firm

Full Vision Inc

Reason for recall

Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.

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

Root cause

Other

Status

Open, Classified

Product code

IOL

Quantity affected

376 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

Date initiated

2023-05-12

Date posted

2023-06-30

Location

Newton, KS