The Recall Desk
HighFDA (Devices)·Z-1825-2015·Announced 2015-07-01

GE Healthcare T2100 Treadmill Recalled for Uncontrolled Walking Belt Motion

GE Healthcare is recalling 11,423 T2100 Treadmills due to a potential safety issue involving uncontrolled motion of the walking belt.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a mechanical defect (uncontrolled motion) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Healthcare is recalling 11,423 units of the T2100 Treadmill, a medical device used for exercise testing and facilitating accurate blood pressure measurements. The recall covers 5,540 units distributed in the United States and 5,883 units distributed outside the United States.

The recall was initiated because GE Healthcare became aware of a potential safety issue involving uncontrolled motion of the walking belt on the affected treadmills. The source text does not specify the exact mechanical cause of the uncontrolled motion or report any specific injuries or illnesses associated with the defect.

Affected units were distributed nationwide in the United States, including Guam, DC, and Puerto Rico, as well as in numerous countries outside the US. Consumers and healthcare facilities should check their T2100 Treadmill serial numbers against the list provided by the FDA to determine if their unit is affected. If a unit is affected, users should stop using the device and contact GE Healthcare for further instructions.

The recalled product

Product
GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.
Manufacturer
GE Healthcare

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically: