GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers 408930-001 Rev E, 408930-002 Rev C, or 2

FDA device recall Z-1285-2015 · posted 2015-03-17 · Terminated

Recall details

Recalling firm

GE Healthcare

Reason for recall

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

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).

Root cause

Process control

Status

Terminated

Product code

IOL

Quantity affected

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

Date initiated

2015-02-16

Date posted

2015-03-17

Date terminated

2017-06-23

Location

Waukesha, WI