Recall Z-0590-2010 ยท BXB Exerciser, Powered
Hocoma AG
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.
| Date | Jan 7, 2010 (initiated May 27, 2009) |
| Status | Terminated |
| Reason | Changes to the stored "sensitivity" values may occur and leads to higher limits in the force and trajectory deviation |
| Root cause | 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 | 7 |
| Distribution | Nationwide Distribution -- including IL, MA, MI, NY and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.