Hocoma AG recalls Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V Kombi; 30005 LokomatPro L6.2 12…

Recall date

June 8, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2418-2020

FDA classification

Class II

Brand / firm

Hocoma AG

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of FL, GA, IL, MI, MN, MO, NE, NY, TX.

Why it was recalled

The motor controller may fail, which can potentially lead to an error in functionality of the Body Weights Support Rope, which means that the rope can go up or down in an uncontrolled way.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V Kombi; 30005 LokomatPro L6.2 120V PE; 30683 LokomatPro L6.2 110V FD PE; 30684 LokomatPro L6.2 110V FD Kombi; 32001 LokomatPro L6.2 110V FD AD Product Usage: The intended use of the Lokomat is to support treadmill training to treat patients with walking disabilities caused by neurological, muscular or bone-related disorders. isokinetic testing and evaluation system