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T2100-ST recallZ-2058-2023 · Full Vision Inc · initiated May 12, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Full Vision Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.

FDA root cause category: Other

What the company is doing

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

Recall details

Recall number
Z-2058-2023
Status
Open, Classified
Initiated by the company
May 12, 2023
Posted by the FDA
Jun 30, 2023
Recalling firm
Full Vision Inc
Quantity
95 units
Product code
IOL
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 description

TRACKMASTER, TREADMILL GE T2100-ST2 220V CHINA, MODEL NUMBER 317-07927GE CHINA

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

UDI/DI 00860176000675, Serial Numbers: GEDC-6765, GEDC-6766, GEDC-6767, GEDC-6768, GEDC-6849, GEDC-6850, GEDC-6851, GEDC-6852, GEDC-6995, GEDC-6996, GEDC-6997, GEDC-6998, GEDC-6999, GEDC-7000, GEDC-7001, GEDC-7002, GEDC-7003, GEDC-7004, GEDC-7005, GEDC-7006, GEDC-7007, GEDC-7008, GEDC-7009, GEDC-7010, GEDC-7011, GEDC-7375, GEDC-7376, GEDC-7377, GEDC-7378, GEDC-7379, GEDC-7380, GEDC-7466, GEDC-7467, GEDC-7468, GEDC-7469, GEDC-7470, GEDC-7471, GEDC-7472, GEDC-7473, GEDC-7474, GEDC-7475, GEDC-7476, GEDC-7477, GEDC-7478, GEDC-7479, GEDC-7480, GEDC-7481, GEDC-7482, GEDC-7888, GEDC-7889, GEDC-7890, GEDC-7892, GEDC-7894, GEDC-7896, GEDC-7897, GEDC-7901, GEDC-7902, GEDC-7906, GEDC-7907, GEDC-7908, GEDC-7913, GEDC-7914, GEDC-7915, GEDC-7916, GEDC-7917, GEDC-7918, GEDC-7919, GEDC-7920, GEDC-7921, GEDC-7922, GEDC-7923, GEDC-7924, GEDC-7925, GEDC-7926, GEDC-7927, GEDC-7928, GEDC-7929, GEDC-7930, GEDC-7931, GEDC-7932, GEDC-7933, GEDC-7934, GEDC-7935, GEDC-7936, GEDC-7937, GEDC-7939, GEDC-7940, GEDC-7941, GEDC-7949, GEDC-7952, GEDC-7953, GEDC-7954, GEDC-7955, GEDC-7956, GEDC-8018

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 92382).

Sources and updates

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