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Terminated

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.

FDA Recall Z-1285-2015 · Posted 2015-03-17

Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeIOL
Date Initiated2015-02-16
Date Terminated2017-06-23
Product Quantity13,345 (5,495 units US, 7,850 units OUS)

Reason for Recall

Potential safety issue due to improper assembly associated with the power cords of T2100 and T2000 Treadmills.

Firm Action

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).

Root Cause

Process control

Distribution Pattern

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.

Official Source

View FDA Recall →

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

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