Device 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.
Z-2135-2020
Product summary
- Event
- Event 85301
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 80 units
- Official record key
device-enforcement:Z-2135-2020
Official wording
Reason: 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.
Code information: 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, RB011-0031, RB011-0032, RB011-0033, RB011-0034, RB011-0035, RB011-0036, RB011-0037, RB011-0038, RB011-0039, RB011-0040, RB011-0041, RB011-0042, RB011-0044, RB011-0045, RB011-0046, RB011-0047, RB011-0048, RB011-0049, RB011-0050, RB011-0051, RB011-0052, RB011-0053, RB011-0054, RB011-0055, RB011-0056, RB011-0057, RB011-0058, RB011-0059, RB011-0060, RB011-0061, RB011-0062, RB011-0063, RB011-0064, RB011-0065, RB011-0066, RB011-0067, RB011-0068, RB011-0069, RB011-0070, RB011-0071, RB011-0072, RB011-0073, RB011-0074, RB011-0075, RB011-0076, RB011-0077, RB011-0078, RB011-0079, RB011-0080, RB011-0081, RB011-0082, RB011-0083, RB011-0084, RB011-0085, RB011-0086, RB011-0087, RB011-0088, RB011-0089, RB011-0090, RB011-0091, and RB011-0092.
Distribution pattern: 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.
Derived failure modes
-
Manufacturing or process control
manufacturing deviation