Z-2053-2023Class II

Trackmaster, Treadmill Tmx428 220V, Model Number 317-07927

Name: Z-2053-2023 Trackmaster, Treadmill Tmx428 220V, Model Number 317-07927
Creator: Full Vision Inc
Published: 2023-05-12
License: https://open.fda.gov/license/

Full Vision Inc / initiated 2023-05-12 / Open, Classified

FDA source

Full Vision Inc began a recall of TRACKMASTER, TREADMILL TMX428 220V, MODEL NUMBER 317-07927 on 2023-05-12. FDA classified it as Class II and gives the reason as "Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2053-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-12
Posted: 2023-06-30
Recalling firm: Full Vision Inc
Product: Trackmaster, Treadmill Tmx428 220V, Model Number 317-07927
Product code: IOL Treadmill, Powered
Reason for recall: Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
FDA 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 in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2053-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2052-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-06-30
Z-2053-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-06-30
Z-2054-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-06-30
Z-2055-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-06-30
Z-2056-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-06-30
Z-2057-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-06-30
Z-2058-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-06-30

Product code IOL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)