Hocoma Lokomat-System with Pediatric Module Software Versions: V4.30, V4.31, V4.31a, V4.31b, V4.31c, V4.32, V4.32a, V5.0
FDA device recall Z-0590-2010 · posted 2010-01-07 · Terminated
Recall details
- Recalling firm
- Hocoma AG
- Reason for recall
- Changes to the stored "sensitivity" values may occur and leads to higher limits in the force and trajectory deviation
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- BXB
- Quantity affected
- 7
- Distribution
- Nationwide Distribution -- including IL, MA, MI, NY and OH.
- Date initiated
- 2009-05-27
- Date posted
- 2010-01-07
- Date terminated
- 2010-02-22
- Location
- Zuerich, Switzerland
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.