Events

Recall of Device Recall AlterG AntiGravity Treadmill

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

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
    67435
  • Event Risk Class
    Class 2
  • Event Number
    Z-1131-2014
  • Event Initiated Date
    2014-01-28
  • Event Date Posted
    2014-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125448
  • 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
    Treadmill, powered - Product Code IOL
  • Reason
    Unapproved material used by vendor in subset of shorts causing them to stretch more than usual and are uncomfortable for patient.
  • Action
    The firm, AlterG, Inc, sent "Medical Device Recall Notification Anti-Gravity Short Exchange" letters dated February 6, 2014 to all customers beginning February 7, 2014 by Federal Express. The letter describes the product, problem and actions to be taken. The customers were instructed to review your inventory of shorts to identify any that are labeled ZIN1212 or ZIN0413 and return any shorts with these labeled production date using the return label provided. If you have any questions about this shorts exchange program or if there are any other ways we can be of assistance to you, please email us at support@alterg.com or call the support team at any time at 510-2705369.

Device

Device Recall AlterG AntiGravity Treadmill
  • Model / Serial
    Product M320, Accessory Shorts with lot numbers XIN1212, XIN0413, XIN0213, XIN0313 and XIN0413,
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution:US (nationwide) and to countries: Australia, Netherlands, United Kingdom, Spain, Germany, France, Denmark, Switzerland, Poland, Slovak Republic, Austria, and United Arab Emirates.
  • Product Description
    Accessory shorts for the AlterG Anti-Gravity treadmill. || Use with the AlterG Anti-Gravity Treadmill for rehabilitation.
  • Manufacturer
    AlterG, Incorporated

Manufacturer

AlterG, Incorporated
  • Manufacturer Address
    AlterG, Incorporated, 48438 Milmont Dr, Fremont CA 94538-7326
  • Manufacturer Parent Company (2017)
    AlterG Inc.
  • Source
    USFDA