Medical device recalls Moderate risk

GE Healthcare recalls GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure measurements and exercise te…

Recall date
March 12, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1825-2015
FDA classification
Class II
Brand / firm
GE Healthcare
Sold / distributed
Nationwide Distribution including Guam, DC, and Puerto Rico. OUS: VIET NAM, VENEZUELA, UZBEKISTAN, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TRINIDAD & TOBAGO, THAILAND, TAIWAN EL SALVADOR, SRILANKA, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, RUSSIA, PORTUGAL PHILIPPINES, PERU, PARA…

Why it was recalled

GE Healthcare has recently become aware of a potential safety issue due to uncontrolled motion of the walking belt on your T2100 Treadmill.

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

What was recalled

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.

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