FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0590-2010
- Recalling firm
- Hocoma AG
- 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.
- Status
- Terminated
- Initiated
- 2009-05-27
- Posted
- 2010-01-07
- Terminated
- 2010-02-22
- 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.
- Lot, serial or model codes
- Software Versions: V4.30, V4.31, V4.31a, V4.31b, V4.31c, V4.32, V4.32a and V5.0x.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BXB
- Firm FEI
- 3003781275
- Firm city
- Zuerich
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28