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U.S. Department of Health and Human Services

Class 2 Device Recall LokomatSystem

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  Class 2 Device Recall LokomatSystem see related information
Date Initiated by Firm May 27, 2009
Date Posted January 07, 2010
Recall Status1 Terminated 3 on February 22, 2010
Recall Number Z-0590-2010
Recall Event ID 52207
Product Classification Exerciser, powered - Product Code BXB
Product Hocoma Lokomat-System with Pediatric Module
Software Versions: V4.30, V4.31, V4.31a, V4.31b, V4.31c, V4.32, V4.32a, V5.0x.

Powered exercise equipment used to apply automated locomoter training for hemiplegic and paraplegic patients.
Code Information Software Versions: V4.30, V4.31, V4.31a, V4.31b, V4.31c, V4.32, V4.32a and V5.0x.
Recalling Firm/
Manufacturer		 Hocoma AG
Florastrasse 47
Zuerich Switzerland
Manufacturer Reason
for Recall		 Changes to the stored "sensitivity" values may occur and leads to higher limits in the force and trajectory deviation
FDA Determined
Cause 2		 Software design
Action Hocoma issued a letter dated May 27, 2009 to Lokomat users informing them of the affected device. Instructions were provided to avoid further problems with the product and users were asked to complete and return the provided Declaration to Field Safety Notice. For further information, contact Hocoma at info@hocoma.com.
Quantity in Commerce 7
Distribution Nationwide Distribution -- including IL, MA, MI, NY and OH.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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