Summary
The FDA issued a Class II for TRACKMASTER, TREADMILL TMX428 220V, MODEL NUMBER 317-07927 by Full Vision Inc. Reason: Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward..
Details
Source
Device Recall
External ID
Z-2053-2023
Action Date
2023-07-12
Status
Ongoing
Category
device
Product Description
TRACKMASTER, TREADMILL TMX428 220V, MODEL NUMBER 317-07927
Lot/Code Info: 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
Quantity Affected: 376 units
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-12
Company
Newton, KS
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 287 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Full Vision Inc has 14 FDA actions in our database, including 14 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Full Vision Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Full Vision Inc have FDA actions?
Full Vision Inc has 14 FDA actions in our database, including 14 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2053-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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