MOTek Medical Recalls Body Weight Support Light Due to Yoke Detachment Risk

Plain-English summary

MOTek Medical B.V. is recalling 80 units of the Body Weight Support (BWS) Light, Model No. RB011. This device is a component of the C-Mill, Grail, and M-Gait systems, designed to facilitate functional gait training for subjects with gait and/or balance impairment by providing dynamic partial vertical unloading during walking on a treadmill.

The recall was initiated after the firm discovered a potential manufacturing deviation in the yoke. In rare occasions, this deviation may result in the yoke detaching from the cable guide. The affected units were distributed worldwide, including in the United States (AZ, CA, FL, KY, MA, MI, NJ, NY, NC, and OH) and in countries such as Argentina, Austria, Belgium, China, Curacao, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Japan, Mexico, Netherlands, Russia, South Korea, Spain, Switzerland, and the United Arab Emirates.

Consumers and healthcare facilities should stop using the affected devices immediately and contact MOTek Medical B.V. for instructions on repair or replacement. The specific serial numbers affected are listed in the official recall documentation.

The recalled product

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

Manufacturer

MOTEK MEDICAL B.V.

Category

Medical Device — Rehabilitation Equipment

Hazard

• mechanical-failure
• fall-injury

Affected units

80

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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