Recall record at a glance
| Official record | Z-1285-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | GE Healthcare |
| Report date | Mar 25, 2015 |
| Recall initiation date | Feb 16, 2015 |
| Quantity | 13,345 (5,495 units US, 7,850 units OUS) |
| Location | Waukesha, WI, United States |
Official product description
GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers 408930-001 Rev E, 408930-002 Rev C, or 2028038-008 Rev B. Also Field Replaceable Unit P/Ns 408930-001 Rev E, 408930-002 Rev C. UPDATE: 3-30-2015: T2100 & T2000 Treadmills with power cord part numbers 408930-001, 408930-002, or 2028038-008 Also Field Replaceable Unit P/Ns 408930-001, 408930-002 Product Usage: Used for 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
Potential safety issue due to improper assembly associated with the power cords of T2100 and T2000 Treadmills.
Distribution information
CONTINENTAL USA DISTRIBUTION INCLUDING DC AND PR. OUS: ARGENTINA AUSTRALIA, AUSTRIA, BANGLADESH, BARBADOS, BHUTAN, BOLIVIA, BRAZIL, BRUNEI, CAMBODIA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, EL SALVADOR, SPAIN, FINLAND, FRANCE, UNITED KIGDOM, GERMANY, GUAM, GUYANA, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITLAY, JAMAICA, JAPAN, REPUBLIC OF KOREA, MACAU, MALYAYSIA, MARTINIQUE, MEXICO, MONACO, MYANMAR, NEPAL, NEW ZEALANAD, NICARAGUA, PANAMA, PARAGUAY, PERU, PHILIPPINES, PORTUGAL, RUSSIA. SINGAPORE, SOUTH KOREA, SRILANKA, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, URUGUAY, UZBEKISTAN, VENEZUELA, VIET NAM.
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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