Recall record at a glance
| Official record | Z-2467-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL |
| Report date | Jul 25, 2018 |
| Recall initiation date | Apr 2, 2018 |
| Quantity | 3,721 devices total |
| Location | Milwaukee, WI, United States |
Official product description
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.
Why the product 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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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