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U.S. Department of Health and Human Services

Class 2 Device Recall Lokomat Pro

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  Class 2 Device Recall Lokomat Pro see related information
Date Initiated by Firm June 08, 2020
Date Posted June 23, 2020
Recall Status1 Open3, Classified
Recall Number Z-2418-2020
Recall Event ID 85857
Product Classification System, isokinetic testing and evaluation - Product Code IKK
Product Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V Kombi; 30005 LokomatPro L6.2 120V PE; 30683 LokomatPro L6.2 110V FD PE; 30684 LokomatPro L6.2 110V FD Kombi; 32001 LokomatPro L6.2 110V FD AD Product Usage: The intended use of the Lokomat is to support treadmill training to treat patients with walking disabilities caused by neurological, muscular or bone-related disorders. isokinetic testing and evaluation system
Code Information All units
Recalling Firm/
Manufacturer		 Hocoma AG
Industriestrasse 4
Volketswil Switzerland
For Additional Information Contact Kevin Walls
720-9625412
Manufacturer Reason
for Recall		 The motor controller may fail, which can potentially lead to an error in functionality of the Body Weights Support Rope, which means that the rope can go up or down in an uncontrolled way.
FDA Determined
Cause 2		 Device Design
Action The firm began notifying affected customers on June 8, 2020. Customers were informed that the motor-controller in their Lokomat may fail, potentially leading to an unintended error in functionality of the Body Weights Support Rope which means that the rope can go up or down in an uncontrolled way. To minimize a risk in relation to a potential failure of the motor-controller, the firm advises you to do the following: - As indicated in the Instruction for Use, permanently monitor patients, which perform a training with the Lokomat. The scenario is especially critical for pediatric patients. - In any case of unusual behavior of the Body Weight Support Rope (e.g. the rope goes up unintendedly) immediately press the Emergency button on the handrail or on the Tele Stop in order to stop the treadmill and the orthosis. Immediately afterwards switch off the power supply in order to stop the rope going up. Afterwards release the patient with the emergency release knob. See Details attached. - Make sure that all possible users of the Lokomat in your institution are informed of this temporary precautionary approach. The firm will continue to work on a technical solution to further minimize the risk of the potential motor control failure.
Quantity in Commerce 494
Distribution Worldwide distribution - US Nationwide distribution including in the states of FL, GA, IL, MI, MN, MO, NE, NY, TX.
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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