GE Medical Systems Ultrasound & Primary Care Diagnostics, LL recalls T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of powered devices intended…

Recall date

April 2, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2467-2018

FDA classification

Class II

Brand / firm

GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

Sold / distributed

Worldwide Distribution - US Nationwide in the states of AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MO, NC, NE, NJ, NV, NY, OH, OK, PA, SC, TN, TX, WA, WI. International distribution to Kenya DEMOCRATIC REPUBLIC OF CONGO, ALGERIA, ARGENTINA, Australia, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADE…

Why it was recalled

A performance issue with customer owned spare parts, T2100 Microflex drive (2026182-002 or 2026182-004), was not addressed with a previous safety correction. If these parts were installed from customer owned stock on the T2100 Treadmill, uncontrolled walking belt motion during a stress exercise test could occur.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Specifically the T210 Treadmill is intended for use in Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.