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Terminated

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.

FDA Recall Z-0590-2010 · Posted 2010-01-07

Recalling FirmHocoma AG
Recall StatusTerminated
Product CodeBXB
Date Initiated2009-05-27
Date Terminated2010-02-22
Product Quantity7

Reason for Recall

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

Firm 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].

Root Cause

Software design

Distribution Pattern

Nationwide Distribution -- including IL, MA, MI, NY and OH.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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