PlainRecalls
FDA Devices Moderate Class II Terminated

GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.

Reported: July 1, 2015 Initiated: March 12, 2015 #Z-1825-2015

Product Description

GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.

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.

Details

Recalling Firm
GE Healthcare
Units 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 SALVADOR, SRILANKA, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, RUSSIA, PORTUGAL PHILIPPINES, PERU, PARAGUAY, PANAMA, PAKISTAN, NEW ZEALAND, NICARAGUA, NEPAL, MYANMAR, MOROCCO, MEXICO, MARTINIQUE, MALAYSIA, LEBANON, KUWAIT, REPUBLIC OF KOREA, KAZAKHSTAN, JAPAN, JAMAICA, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, HON GONG, GERMANY, FRANCE, FINLAND, ETHIOPIA, EGYPT, ECUADOR, DOMINICAN REPUBLIC, COSTA RICA, COLOMBIA, CHINA, CHILE , CAYMAN ISLAND , CANADA, CAMBODIA, BRUNEI DARUSSALAM, BRAZIL, BOLIVIA, BHUTAN, BANGLADESH, BAHRAIN, AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.. Recalled by GE Healthcare. Units affected: 11,423 (5,540 units US, 5,883 units OUS.
Why was this product recalled?
GE Healthcare has recently become aware of a potential safety issue due to uncontrolled motion of the walking belt on your T2100 Treadmill.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 1, 2015. Severity: Moderate. Recall number: Z-1825-2015.