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U.S. Department of Health and Human Services

Class 2 Device Recall Body Weight Support (BWS) Light

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  Class 2 Device Recall Body Weight Support (BWS) Light see related information
Date Initiated by Firm July 29, 2019
Create Date May 27, 2020
Recall Status1 Open3, Classified
Recall Number Z-2135-2020
Recall Event ID 85301
Product Classification Exerciser, powered - Product Code BXB
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.
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.
Recalling Firm/
Manufacturer		 MOTEK MEDICAL B.V.
Hogehilweg 18
18 Unit C
Amsterdam Netherlands
For Additional Information Contact Kevin Walls
720-9625412
Manufacturer Reason
for Recall		 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 Determined
Cause 2		 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/or prevention action: "In all cases, if you are treating patients with cranial deficiencies, stop using the system for these patients immediately". Three possible options were provided. Customers were asked to select one that is most appropriate for their institute and send them this information via the Advisory Notice Confirmation: A. You request a Yoke Replacement Kit to be sent to you directly, such that a skilled person from your institute can do the replacement under the firm's remote supervision. The replacement consists of removing two easily accessible bolts, replacing the affected components, and reinserting two new bolts. Verification will require to take two pictures of the reinserted bolts, and confirmation by the firm is needed before you can use the system again for patients with cranial deficiencies. Detailed instructions will be provided. B. Or, you do not treat patients with cranial deficiencies, and do not want to order a Yoke Replacement Kit. If so, you can continue using the system as normal and can consider this Field Safety Notice to be not applicable for your usage (even though we still need you to send in the Advisory Notice Confirmation). In the next service visit, we will replace the yoke to further minimize any risk. C. Or, you do treat patients with cranial deficiencies, but you do not want to order a Yoke Replacement Kit. In this case, you
Quantity in Commerce 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 Korea, Spain, Switzerland, and United Arab Emirates.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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