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.
This recall has been terminated (originally issued January 7, 2010).
- Recall Initiated
- May 27, 2009
- Posted
- January 7, 2010
- Terminated
- February 22, 2010
- Recall Number
- Z-0590-2010
- Quantity
- 7
- Official Source
- View on FDA website ↗
Reason for Recall
Changes to the stored "sensitivity" values may occur and leads to higher limits in the force and trajectory deviation
Distribution
Nationwide Distribution -- including IL, MA, MI, NY and OH.
Lot / Code Info
Software Versions: V4.30, V4.31, V4.31a, V4.31b, V4.31c, V4.32, V4.32a and V5.0x.
Root Cause
Software design
Action Taken
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.