Events

Recall of Device Recall LokomatSystem

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hocoma AG.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52207
  • Event Risk Class
    Class 2
  • Event Number
    Z-0590-2010
  • Event Initiated Date
    2009-05-27
  • Event Date Posted
    2010-01-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-02-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82522
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Exerciser, powered - Product Code BXB
  • Reason
    Changes to the stored "sensitivity" values may occur and leads to higher limits in the force and trajectory deviation.
  • 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.

Device

Device Recall LokomatSystem
  • Model / Serial
    Software Versions: V4.30, V4.31, V4.31a, V4.31b, V4.31c, V4.32, V4.32a and V5.0x.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- including IL, MA, MI, NY and OH.
  • Product Description
    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.
  • Manufacturer
    Hocoma AG

Manufacturer

Hocoma AG
  • Manufacturer Address
    Hocoma AG, Florastrasse 47, Zuerich Switzerland
  • Manufacturer Parent Company (2017)
    Hocoma Ag
  • Source
    USFDA