Z-0590-2010

Hocoma Lokomat-System with Pediatric Module Software Versions: V4.30, V4.31, V4.31a, V4.31b, V4.31c, V4.32...

Name: Z-0590-2010 Hocoma Lokomat-System with Pediatric Module Software Versions: V4.30, V4.31, V4.31a, V4.31b, V4.31c, V4.32...
Creator: Hocoma AG
Published: 2009-05-27
License: https://open.fda.gov/license/

Hocoma AG / initiated 2009-05-27 / Terminated / root cause: software

FDA source

Hocoma AG began a recall of 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... on 2009-05-27. The reason FDA records is "Changes to the stored "sensitivity" values may occur and leads to higher limits in the force and trajectory deviation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0590-2010
Status: Terminated
Initiated: 2009-05-27
Posted: 2010-01-07
Terminated: 2010-02-22
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.
Product code: BXB Exerciser, Powered
Reason for recall: Changes to the stored "sensitivity" values may occur and leads to higher limits in the force and trajectory deviation
Root cause tag: software
FDA 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 [email protected].
Quantity in commerce: 7
Distribution: Nationwide Distribution -- including IL, MA, MI, NY and OH.
Product codes and lots: Software Versions: V4.30, V4.31, V4.31a, V4.31b, V4.31c, V4.32, V4.32a and V5.0x.

Product code BXB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)