TRACKMASTER, TREADMILL TMX428 110V, MODEL NUMBER 317-07926
- Company
- Full Vision Inc
- Recall Initiated
- May 12, 2023
- Posted
- June 30, 2023
- Recall Number
- Z-2052-2023
- Quantity
- 565 units
- Firm Location
- Newton, KS
Reason for Recall
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
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
Lot / Code Info
UDI/DI 00860176000606, Serial Numbers: FVDC-7585, FVDC-7586, FVDC-7587, FVDC-7588, FVDC-7589, FVDC-7590, FVDC-7591, FVDC-7592, FVDC-7593, FVDC-7594, FVDC-7595, FVDC-7596, FVDC-7597, FVDC-7598, FVDC-7599, FVDC-7600, FVDC-7601, FVDC-7603, FVDC-7604, FVDC-7605, FVDC-7606, FVDC-7607, FVDC-7608, FVDC-7609, FVDC-7610, FVDC-7611, FVDC-7612, FVDC-7613, FVDC-7614, FVDC-7615, FVDC-7616, FVDC-7617, FVDC-7618, FVDC-7619, FVDC-7620, FVDC-7621, FVDC-7622, FVDC-7623, FVDC-7624, FVDC-7625, FVDC-7626, FVDC-7627, FVDC-7628, FVDC-7629, FVDC-7640, FVDC-7666, FVDC-7667, FVDC-7668, FVDC-7669, FVDC-7670, FVDC-7671, FVDC-7672, FVDC-7673, FVDC-7674, FVDC-7675, FVDC-7676, FVDC-7677, FVDC-7678, FVDC-7679, FVDC-7680, FVDC-7681, FVDC-7682, FVDC-7683, FVDC-7684, FVDC-7685, FVDC-7687, FVDC-7688, FVDC-7689, FVDC-7690, FVDC-7691, FVDC-7692, FVDC-7693, FVDC-7694, FVDC-7695, FVDC-7696, FVDC-7697, FVDC-7698, FVDC-7699, FVDC-7700, FVDC-7701, FVDC-7702, FVDC-7703, FVDC-7704, FVDC-7705, FVDC-7706, FVDC-7717, FVDC-7719, FVDC-7720, FVDC-7721, FVDC-7722, FVDC-7723, FVDC-7724, FVDC-7725, FVDC-7726, FVDC-7727, FVDC-7728, FVDC-7729, FVDC-7730, FVDC-7731, FVDC-7732, FVDC-7733, FVDC-7734, FVDC-7735, FVDC-7736, FVDC-7737, FVDC-7738, FVDC-7782, FVDC-7783, FVDC-7785, FVDC-7787, FVDC-7788, FVDC-7789, FVDC-7790, FVDC-7791, FVDC-7792, FVDC-7793, FVDC-7794, FVDC-7795, FVDC-7796, FVDC-7797, FVDC-7798, FVDC-7799, FVDC-7800, FVDC-7811, FVDC-7812, FVDC-7813, FVDC-7814, FVDC-7815, FVDC-7816, FVDC-7817, FVDC-7818, FVDC-7819, FVDC-7836, FVDC-7837, FVDC-7838, FVDC-7839, FVDC-7840, FVDC-7841, FVDC-7842, FVDC-7843, FVDC-7844, FVDC-7845, FVDC-7846, FVDC-7847, FVDC-7848, FVDC-7849, FVDC-7850, FVDC-7864, FVDC-7865, FVDC-7866, FVDC-7867, FVDC-7868, FVDC-7869, FVDC-7870, FVDC-7871, FVDC-7872, FVDC-7873, FVDC-7874, FVDC-7875, FVDC-7876, FVDC-7877, FVDC-7878, FVDC-7879, FVDC-7880, FVDC-7881, FVDC-7882, FVDC-7883, FVDC-7884, FVDC-7885, FVDC-7886, FVDC-7887, FVDC-7889, FVDC-7890, FVDC-7899, FVDC-7915, FVDC-7916, FVDC-7917, FVDC-7918, FVDC-7919, FVDC-7920, FVDC-7921, FVDC-7922, FVDC-7923, FVDC-7924, FVDC-7925, FVDC-7926, FVDC-7943, FVDC-7944, FVDC-7945, FVDC-7946, FVDC-7947, FVDC-7964, FVDC-7965, FVDC-7966, FVDC-7983, FVDC-7984, FVDC-7985, FVDC-7986, FVDC-7987, FVDC-7988, FVDC-7989, FVDC-7990, FVDC-7991, FVDC-7992, FVDC-7993, FVDC-7994, FVDC-7995, FVDC-8001, FVDC-8002, FVDC-8003, FVDC-8004, FVDC-8005, FVDC-8006, FVDC-8007, FVDC-8008, FVDC-8009, FVDC-8010, FVDC-8011, FVDC-8012, FVDC-8013, FVDC-8014, FVDC-8015, FVDC-8016, FVDC-8017, FVDC-8018, FVDC-8019, FVDC-8020, FVDC-8021, FVDC-8022, FVDC-8023, FVDC-8024, FVDC-8025, FVDC-8029, FVDC-8030, FVDC-8031, FVDC-8032, FVDC-8033, FVDC-8034, FVDC-8035, FVDC-8036, FVDC-8037, FVDC-8038, FVDC-8039, FVDC-8040, FVDC-8041, FVDC-8042, FVDC-8043, FVDC-8044, FVDC-8045, FVDC-8046, FVDC-8047, FVDC-8048, FVDC-8049, FVDC-8050, FVDC-8051, FVDC-8052, FVDC-8053, FVDC-8054, FVDC-8055, FVDC-8056, FVDC-8110, FVDC-8111, FVDC-8112, FVDC-8113, FVDC-8114, FVDC-8115, FVDC-8116, FVDC-8117, FVDC-8118, FVDC-8119, FVDC-8120, FVDC-8121, FVDC-8122, FVDC-8123, FVDC-8124, FVDC-8125, FVDC-8127, FVDC-8128, FVDC-8129, FVDC-8130, FVDC-8131, FVDC-8132, FVDC-8133, FVDC-8134, FVDC-8135, FVDC-8136, FVDC-8137, FVDC-8138, FVDC-8139, FVDC-8140, FVDC-8141, FVDC-8142, FVDC-8143, FVDC-8144, FVDC-8145, FVDC-8146, FVDC-8147, FVDC-8148, FVDC-8149, FVDC-8150, FVDC-8151, FVDC-8152, FVDC-8153, FVDC-8154, FVDC-8155, FVDC-8156, FVDC-8193, FVDC-8194, FVDC-8195, FVDC-8196, FVDC-8197, FVDC-8198, FVDC-8199, FVDC-8200, FVDC-8201, FVDC-8202, FVDC-8213, FVDC-8214, FVDC-8215, FVDC-8216, FVDC-8217, FVDC-8218, FVDC-8219, FVDC-8220, FVDC-8221, FVDC-8222, FVDC-8223, FVDC-8224, FVDC-8225, FVDC-8226, FVDC-8227, FVDC-8228, FVDC-8229, FVDC-8230, FVDC-8231, FVDC-8232, FVDC-8233, FVDC-8234, FVDC-8245, FVDC-8246, FVDC-8247, FVDC-8248, FVDC-8249, FVDC-8250, FVDC-8251, FVDC-8252, FVDC-8253, FVDC-8254, FVDC-8256, FVDC-8257, FVDC-8258, FVDC-8259, FVDC-8260, FVDC-8261, FVDC-8262, FVDC-8263, FVDC-8264, FVDC-8265, FVDC-8266, FVDC-8269.FVDC-8273, FVDC-8274, FVDC-8275, FVDC-8276, FVDC-8277, FVDC-8278, FVDC-8279, FVDC-8280, FVDC-8281, FVDC-8282, FVDC-8283, FVDC-8284, FVDC-8285, FVDC-8286, FVDC-8287, FVDC-8288, FVDC-8289, FVDC-8290, FVDC-8291, FVDC-8292, FVDC-8293, FVDC-8294, FVDC-8295, FVDC-8296, FVDC-8297, FVDC-8298, FVDC-8299, FVDC-8300, FVDC-8301, FVDC-8302, FVDC-8303, FVDC-8304, FVDC-8305, FVDC-8306, FVDC-8307, FVDC-8308, FVDC-8309, FVDC-8326, FVDC-8327, FVDC-8328, FVDC-8329, FVDC-8330, FVDC-8331, FVDC-8332, FVDC-8333, FVDC-8334, FVDC-8335, FVDC-8336, FVDC-8337, FVDC-8338, FVDC-8339, FVDC-8340, FVDC-8341, FVDC-8342, FVDC-8343, FVDC-8344, FVDC-8345, FVDC-8346, FVDC-8347, FVDC-8348, FVDC-8349, FVDC-8350, FVDC-8351, FVDC-8352, FVDC-8353, FVDC-8354, FVDC-8355, FVDC-8396, FVDC-8397, FVDC-8398, FVDC-8399, FVDC-8426, FVDC-8427, FVDC-8428, FVDC-8429, FVDC-8430, FVDC-8431, FVDC-8432, FVDC-8433, FVDC-8434, FVDC-8435, FVDC-8456, FVDC-8457, FVDC-8458, FVDC-8459, FVDC-8460, FVDC-8461, FVDC-8462, FVDC-8463, FVDC-8464, FVDC-8465, FVDC-8494, FVDC-8495, FVDC-8496, FVDC-8497, FVDC-8498, FVDC-8499, FVDC-8500, FVDC-8501, FVDC-8502, FVDC-8503, FVDC-8504, FVDC-8505, FVDC-8506, FVDC-8507, FVDC-8508, FVDC-8514, FVDC-8515, FVDC-8516, FVDC-8517, FVDC-8518, FVDC-8519, FVDC-8520, FVDC-8521, FVDC-8522, FVDC-8523, FVDC-8559, FVDC-8560, FVDC-8561, FVDC-8562, FVDC-8563, FVDC-8564, FVDC-8565, FVDC-8566, FVDC-8567, FVDC-8568, FVDC-8569, FVDC-8570, FVDC-8571, FVDC-8572, FVDC-8573, FVDC-8599, FVDC-8600, FVDC-8601, FVDC-8602, FVDC-8603, FVDC-8604, FVDC-8605, FVDC-8606, FVDC-8607, FVDC-8608, FVDC-8609, FVDC-8610, FVDC-8611, FVDC-8612, FVDC-8613, FVDC-8614, FVDC-8615, FVDC-8616, FVDC-8629, FVDC-8630, FVDC-8648, FVDC-8654, FVDC-8655, FVDC-8656, FVDC-8657, FVDC-8658, FVDC-8659, FVDC-8660, FVDC-8661, FVDC-8662, FVDC-8663, FVDC-8674, FVDC-8675, FVDC-8676, FVDC-8677, FVDC-8678, FVDC-8679, FVDC-8680, FVDC-8681, FVDC-8682, FVDC-8683, FVDC-8697, FVDC-8698, FVDC-8699, FVDC-8700, FVDC-8701, FVDC-8757, FVDC-8758, FVDC-8759, FVDC-8760, FVDC-8761, FVDC-8762, FVDC-8763, FVDC-8814, FVDC-8819, FVDC-8820, FVDC-8821, FVDC-8822, FVDC-8823, FVDC-8824, FVDC-8825, FVDC-8826, FVDC-8827, FVDC-8828, FVDC-8860, FVDC-8861, FVDC-8862, FVDC-8863, FVDC-8864, FVDC-8865, FVDC-8866, FVDC-8867, FVDC-8868, FVDC-8869
Root 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