| Class 2 Device Recall LokomatSystem | |
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 |
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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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