MOTek Medical Recalls Body Weight Support Light Due to Yoke Detachment Risk
MOTek Medical is recalling 80 units of the Body Weight Support Light (Model RB011) because a manufacturing deviation may cause the yoke to detach from the cable guide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical defect that could lead to injury (yoke detachment), but the source text does not report any actual injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
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…
- Manufacturer
- MOTEK MEDICAL B.V.
- 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.
Lot numbers (20)
- AS9924-00-0002
- RB011-00-0005
- RB011-00-0006
- RB011-00-0010
- RB011-00-0012
- RB011-00-0015
- RB011-00-0017
- RB011-00-0018
- RB011-00-0019
- RB011-00-0020
- RB011-00-0021
- RB011-0022
- RB011-0023
- RB011-0024
- RB011-0025
- RB011-0026
- RB011-0027
- RB011-0028
- RB011-0029
- RB011-0030
Distribution
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