Class 2 Device Recall FULL VISION

• Date Initiated by Firm: May 12, 2023
• Date Posted: June 30, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2052-2023
• Recall Event ID: 92382
• Product Classification: Treadmill, powered - Product Code IOL
• Product: TRACKMASTER, TREADMILL TMX428 110V, MODEL NUMBER 317-07926
• Code Information: 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
• Recalling Firm/ Manufacturer: Full Vision Inc; 3017 Full Vision Dr; Newton KS 67114-9750
• For Additional Information Contact: 316-283-3344
• Manufacturer Reason for Recall: Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
• FDA Determined 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 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
• Quantity in Commerce: 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, United Kingdom, Uruguay
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.