Terminated

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.

FDA Recall Z-2467-2018 · Posted None

Recalling FirmGE Medical Systems Ultrasound & Primary Care Diagnostics, LL

Recall StatusTerminated

Product CodeIOL

Date Initiated2018-04-02

Date Terminated2024-04-30

Product Quantity3,721 devices total

Reason for Recall

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.

Firm Action

GE Healthcare sent an Urgent Medical Device Correction letter dated March 30, 2018 to customers. The letter identified the affected product, problem and actions to be taken. The letter stated that GE Healthcare will correct all affected products at no cost. Customers were asked to complete and return the attached "Customer Response" form via email to [email protected] and a GE Healthcare representative will contact you to arrange for a correction if necessary. For questions contact GE Healthcare Service at 1-800-437-1171 or your local service Representative.

Root Cause

Device Design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.