Recall Z-1285-2015 ยท IOL Treadmill, Powered
GE Healthcare
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
| Date | Mar 17, 2015 (initiated Feb 16, 2015) |
| Status | Terminated |
| Reason | Potential safety issue due to improper assembly associated with the power cords of T2100 and T2000 Treadmills. |
| Root cause | Process control |
| 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 Affecte |
| 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, G |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.