FDA-Device2018-07-25Class II
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.
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Hazard
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.
Sold states
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, BANGLADESH, BELGIUM, BHUTAN, BOLIVIA, BOSNIA-HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, BURMA(MYANMAR), CAMBODIA, CAMEROON, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DEMOCRATIC REPUBLIC OF CONGO, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, GEORGIA, GERMANY, GREECE, GUAM, Hong Kong, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JORDAN, AZAKHSTAN, KENYA, KOREA, KUWAIT, LEBANON, LIBYA, MACEDONIA, ALAYSIA, MAURITIUS, MEXICO, MOLDOVA, MOROCCO, NAMIBIA, NEPAL, NEW CALEDONIA, NEW ZEALAND, Nigeria, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PUERTO RICO, QATAR, REUNION, ROMANIA, RUSSIA, SERBIA--MONTENEGRO, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SUDAN, SWITZERLAND, SYRIA, TAIWAN, TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARAB EMIRATES, URUGUAY, UZBEKISTAN, VENEZUELA, VIETNAM, Virgin Islands, YEMEN.
Affected count
3,721 devices total
Manufactured in
9900 W Innovation Dr, Milwaukee, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2467-2018Don't want to check this manually?
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