Home / Recalls / Medical Devices
MOTEK MEDICAL B.V. recalls Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to f
Recalled June 3, 2020 · FDA recall Z-2135-2020 · MOTEK MEDICAL B.V
Hazard
The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light that in rare occasions may result in the yoke detaching from the cable guide. · FDA Class II
Units
80 units
Sold at
Worldwide distribution - US Nationwide distributions including in the states of AZ, CA, FL, KY, MA, MI, NJ, NY, NC, and OH. The countries of Argentina, Austria, Belgium, China, Curacao, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Japan, Mexico, Netherlands, Russia, South Korea, Spain, Switzerland, and United Arab Emirates.
Description
The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light that in rare occasions may result in the yoke detaching from the cable guide.
Product
Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to facilitate functional gait training of subjects with gait and/or balance impairment by providing dynamic partial vertical unloading during walking on a treadmill. The device will be used as an assistive device for gait deficiency rehabilitation and research purposes.
Manufacturer(s)
MOTEK MEDICAL B.V.
Made in
Netherlands
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →