Full Vision Inc: TRACKMASTER, TREADMILL TMX428 220V, MODEL NUMBER 317-07927

Recall number

Z-2053-2023

Recalling firm

Full Vision Inc

Product

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

Status

Open, Classified

Initiated

2023-05-12

Posted

2023-06-30

Terminated

not on file

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 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

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, Peru, Philippines, Saudi Arabia, Singapore, SOUTH KOREA, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uruguay

Lot, serial or model codes

UDI/DI 00860176000613, Serial Numbers: FVDC-7630, FVDC-7631, FVDC-7633, FVDC-7634, FVDC-7635, FVDC-7636, FVDC-7637, FVDC-7638, FVDC-7639, FVDC-7647, FVDC-7648, FVDC-7649, FVDC-7650, FVDC-7651, FVDC-7652, FVDC-7653, FVDC-7654, FVDC-7655, FVDC-7656, FVDC-7657, FVDC-7658, FVDC-7659, FVDC-7660, FVDC-7661, FVDC-7662, FVDC-7663, FVDC-7664, FVDC-7665, FVDC-7707, FVDC-7708, FVDC-7709, FVDC-7710, FVDC-7711, FVDC-7712, FVDC-7713, FVDC-7714, FVDC-7715, FVDC-7716, FVDC-7749, FVDC-7750, FVDC-7751, FVDC-7752, FVDC-7753, FVDC-7754, FVDC-7755, FVDC-7756, FVDC-7757, FVDC-7758, FVDC-7759, FVDC-7760, FVDC-7761, FVDC-7762, FVDC-7763, FVDC-7764, FVDC-7765, FVDC-7766, FVDC-7767, FVDC-7768, FVDC-7769, FVDC-7770, FVDC-7771, FVDC-7772, FVDC-7773, FVDC-7774, FVDC-7775, FVDC-7776, FVDC-7777, FVDC-7778, FVDC-7779, FVDC-7780, FVDC-7784, FVDC-7801, FVDC-7802, FVDC-7803, FVDC-7804, FVDC-7805, FVDC-7806, FVDC-7807, FVDC-7808, FVDC-7809, FVDC-7810, FVDC-7826, FVDC-7827, FVDC-7828, FVDC-7829, FVDC-7830, FVDC-7831, FVDC-7832, FVDC-7833, FVDC-7834, FVDC-7835, FVDC-7851, FVDC-7852, FVDC-7853, FVDC-7854, FVDC-7855, FVDC-7856, FVDC-7857, FVDC-7858, FVDC-7859, FVDC-7860, FVDC-7861, FVDC-7862, FVDC-7863, FVDC-7900, FVDC-7901, FVDC-7902, FVDC-7903, FVDC-7904, FVDC-7905, FVDC-7906, FVDC-7907, FVDC-7908, FVDC-7909, FVDC-7910, FVDC-7911, FVDC-7912, FVDC-7913, FVDC-7914, FVDC-7928, FVDC-7929, FVDC-7930, FVDC-7931, FVDC-7932, FVDC-7933, FVDC-7934, FVDC-7935, FVDC-7936, FVDC-7937, FVDC-7938, FVDC-7939, FVDC-7940, FVDC-7941, FVDC-7942, FVDC-7948, FVDC-7949, FVDC-7950, FVDC-7951, FVDC-7952, FVDC-7953, FVDC-7954, FVDC-7955, FVDC-7956, FVDC-7957, FVDC-7967, FVDC-7968, FVDC-7969, FVDC-7970, FVDC-7971, FVDC-7972, FVDC-7973, FVDC-7974, FVDC-7975, FVDC-7976, FVDC-7977, FVDC-7978, FVDC-7979, FVDC-7980, FVDC-7981, FVDC-7982, FVDC-7996, FVDC-7997, FVDC-7998, FVDC-7999, FVDC-8000, FVDC-8026, FVDC-8027, FVDC-8028, FVDC-8064, FVDC-8065, FVDC-8066, FVDC-8067, FVDC-8068, FVDC-8108, FVDC-8109, FVDC-8126, FVDC-8157, FVDC-8158, FVDC-8159, FVDC-8160, FVDC-8161, FVDC-8162, FVDC-8163, FVDC-8164, FVDC-8165, FVDC-8166, FVDC-8172, FVDC-8173, FVDC-8174, FVDC-8175, FVDC-8176, FVDC-8177, FVDC-8178, FVDC-8179, FVDC-8180, FVDC-8181, FVDC-8182, FVDC-8183, FVDC-8184, FVDC-8185, FVDC-8190, FVDC-8191, FVDC-8203, FVDC-8204, FVDC-8205, FVDC-8206, FVDC-8207, FVDC-8208, FVDC-8209, FVDC-8210, FVDC-8211, FVDC-8212, FVDC-8235, FVDC-8236, FVDC-8237, FVDC-8238, FVDC-8239, FVDC-8240, FVDC-8241, FVDC-8242, FVDC-8243, FVDC-8244, FVDC-8267, FVDC-8268, FVDC-8270, FVDC-8271, FVDC-8311, FVDC-8312, FVDC-8313, FVDC-8314, FVDC-8315, FVDC-8356, FVDC-8357, FVDC-8358, FVDC-8359, FVDC-8360, FVDC-8361, FVDC-8362, FVDC-8363, FVDC-8364, FVDC-8365, FVDC-8366, FVDC-8367, FVDC-8368, FVDC-8369, FVDC-8370, FVDC-8371, FVDC-8372, FVDC-8373, FVDC-8374, FVDC-8375, FVDC-8376, FVDC-8377, FVDC-8378, FVDC-8379, FVDC-8380, FVDC-8381, FVDC-8382, FVDC-8383, FVDC-8384, FVDC-8385, FVDC-8390, FVDC-8391, FVDC-8392, FVDC-8411, FVDC-8417, FVDC-8418, FVDC-8419, FVDC-8436, FVDC-8437, FVDC-8438, FVDC-8439, FVDC-8440, FVDC-8441, FVDC-8442, FVDC-8443, FVDC-8444, FVDC-8445, FVDC-8466, FVDC-8467, FVDC-8468, FVDC-8469, FVDC-8470, FVDC-8471, FVDC-8472, FVDC-8473, FVDC-8474, FVDC-8475, FVDC-8476, FVDC-8477, FVDC-8478, FVDC-8479, FVDC-8480, FVDC-8481, FVDC-8482, FVDC-8483, FVDC-8509, FVDC-8510, FVDC-8511, FVDC-8512, FVDC-8513, FVDC-8529, FVDC-8530, FVDC-8531, FVDC-8540, FVDC-8552, FVDC-8574, FVDC-8575, FVDC-8576, FVDC-8577, FVDC-8578, FVDC-8579, FVDC-8580, FVDC-8581, FVDC-8582, FVDC-8583, FVDC-8584, FVDC-8585, FVDC-8586, FVDC-8587, FVDC-8588, FVDC-8589, FVDC-8590, FVDC-8591, FVDC-8592, FVDC-8593, FVDC-8594, FVDC-8595, FVDC-8596, FVDC-8597, FVDC-8598, FVDC-8635, FVDC-8636, FVDC-8637, FVDC-8638, FVDC-8639, FVDC-8640, FVDC-8641, FVDC-8642, FVDC-8643, FVDC-8644, FVDC-8647, FVDC-8649, FVDC-8650, FVDC-8664, FVDC-8665, FVDC-8666, FVDC-8667, FVDC-8668, FVDC-8669, FVDC-8670, FVDC-8671, FVDC-8672, FVDC-8673, FVDC-8684, FVDC-8685, FVDC-8686, FVDC-8687, FVDC-8688, FVDC-8689.FVDC-8690, FVDC-8691, FVDC-8692, FVDC-8693, FVDC-8694, FVDC-8695, FVDC-8696, FVDC-8727, FVDC-8728, FVDC-8729, FVDC-8764, FVDC-8765, FVDC-8766, FVDC-8767, FVDC-8807, FVDC-8808

510(k) numbers

not on file

PMA numbers

not on file

Product code

IOL

Firm FEI

3001040337

Firm city

Newton

Firm state

KS

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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