Recall Z-2135-2020 ยท BXB Exerciser, Powered
MOTEK MEDICAL B.V.
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.
| Date | Jul 29, 2019 |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | On 07/29/2019 the firm notified their customers of the Field Safety Notice: BWS-L Yoke 2019 letter sent via email. The firm informed their customers to share the notice with all those within their organizations who need to be aware. Customers were asked to confirm receipt of the Field Safety Notice. Additionally, customers were asked to reply by email to support@motekforcelink.com and attach a completed and signed copy of the Advisory Notice Confirmation (last page of the notice) within 10 business days of receipt of the notice. The firm provided the following information corrective and/ |
| Quantity | 80 units |
| Distribution | 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 Kor |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.