FDA Recall
Terminated
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.
Recall: Z-0590-2010
·
Initiated May 27, 2009
Recall
- Recall Number
- Z-0590-2010
- Event Number
- 52207
- Firm
- Hocoma AG Florastrasse 47 Zuerich Switzerland
- FEI Number
- 3003781275
- Product Code
- BXB
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- May 27, 2009
- Posted
- January 7, 2010
- Terminated
- February 22, 2010
Description
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.
Reason
Changes to the stored "sensitivity" values may occur and leads to higher limits in the force and trajectory deviation
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 [email protected].
Distribution
Nationwide Distribution -- including IL, MA, MI, NY and OH.
Quantity
7