FDA Device

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.

Hazard

Changes to the stored "sensitivity" values may occur and leads to higher limits in the force and trajectory deviation

What You Should Do

Remedy

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.

Products

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 h
Brand
Hocoma AG Florastrasse 47 Zuerich Switzerland
UPC
Software Versions: V4.30, V4.31, V4.31a, V4.31b, V4.31c, V4.32, V4.32a and V5.0x.

Units Affected

7