GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure measurements and exercise tes

FDA device recall Z-1825-2015 · posted 2015-06-22 · Terminated

Recall details

Recalling firm

GE Healthcare

Reason for recall

GE Healthcare has recently become aware of a potential safety issue due to uncontrolled motion of the walking belt on your T2100 Treadmill.

Action taken

General Healthcare sent an Urgent Medical Device Correction letter (GEHC Ref# 30074) dated March 12, 2015, to all affected consignees. The letter was addressed to Director of Biomedical Engineering, Chief of Nursing and 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.

Root cause

Device Design

Status

Terminated

Product code

IOL

Quantity affected

11,423 (5,540 units US, 5,883 units OUS

Distribution

Nationwide Distribution including Guam, DC, and Puerto Rico. OUS: VIET NAM, VENEZUELA, UZBEKISTAN, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TRINIDAD & TOBAGO, THAILAND, TAIWAN EL SALVADO

Date initiated

2015-03-12

Date posted

2015-06-22

Date terminated

2017-09-29

Location

Waukesha, WI