Recall Z-1285-2015
GE Healthcare · initiated February 16, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Mfg Lot or Serial # 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-002 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-002 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001…
Reason for recall
Potential safety issue due to improper assembly associated with the power cords of T2100 and T2000 Treadmills.
FDA-determined cause: Process control
Action taken
GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref#30073 dated February 16, 2015. The letter was addressed to Director of Biomedical Engineering, Chief of Nursing, & Healthcare Administrator / Risk Manager. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. UPDATE 3-30-2015: A second revised letter was sent on March 31, 2015. NOTE: this revised notification includes an update to the Affected Product Details section to include all revisions of power cords manufactured within the date range indicated. (The previous notification referenced only revisions B, C, & E).
Details
- Recall number
- Z-1285-2015
- Initiated
- February 16, 2015
- Posted by FDA
- March 17, 2015
- Terminated
- June 23, 2017
- Product code
- IOL – Treadmill, Powered
- Quantity
- 13,345 (5,495 units US, 7,850 units OUS)
- Distribution
- 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…
- Recalling firm
- GE Healthcare, Waukesha, WI