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U.S. Department of Health and Human Services

Class 2 Device Recall FULL VISION INC. TRACKMASTER

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  Class 2 Device Recall FULL VISION INC. TRACKMASTER see related information
Date Initiated by Firm August 31, 2022
Date Posted December 03, 2022
Recall Status1 Open3, Classified
Recall Number Z-0365-2023
Recall Event ID 90995
Product Classification Treadmill, powered - Product Code IOL
Product FULL VISION INC. TRACKMASTER,TREADMILL TMX428 220V, Model #317-07927
Code Information 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
Recalling Firm/
Manufacturer		 Full Vision Inc
3017 Full Vision Dr
Newton KS 67114-9750
For Additional Information Contact Mr. Doug Pauls
316-283-3344
Manufacturer Reason
for Recall		 This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnetic Safety Tether, that when the magnet is pulled loose as during a fall, the treadmill may fail to stop.
FDA Determined
Cause 2		 Other
Action The firm began sending URGENT MEDICAL DEVICE CORRECTION notices its consignees by email beginning 09/13/2022. The distributors were provided with a letter to distribute to their customers (end users) The notice explained the issue, risk to health, and requested the following actions be taken: "Actions to be taken by the Customer/User: A simple test can be performed to determine if the unit has the incorrect component installed on the PCB Assembly. The user should turn the device on. Then cycle the power with the power switch by turning it off, waiting 5 seconds, then turn it back on. Start the belt at 2 mph and pull the Magnetic Tether. If the assembly has the incorrect component the device should fail to stop. If the assembly has the correct component the device should stop. The assemblies that fail to stop should be replaced with the c-clip style safety tethers, provided by Full Vision to the distributors and end users. To continue using the treadmill with the Magnetic Tether assemblies until they can be replaced, you can prevent this condition from occurring by cycling the power for 30 seconds before turning the device back on. Product Correction: Full Vision has scrapped all the non-conforming components (Magnetic Safety Tether and PCB Board Assembly) from the inventory. All nonconforming components will be replaced."
Quantity in Commerce 38 units
Distribution Wi, GA, NY, Mexico
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.
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