Events

Safety Alert Or Field Safety Notices for AlterG Anti-Gravity treadmill, model M320, used for rehabilitation after surgery

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Alter G.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Date
    2017-12-21
  • Event Date Posted
    2017-12-21
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/alterg-anti-gravity-treadmill-model-m320-used-for-rehabilitation-after-surgery-unexpected-surge-to-maximum-speed-and-failure-of-the-emergency-stop
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
  • Extra notes in the data
  • Reason
    Risk of injury to the patient if the treadmill suddenly goes to top speed.
  • Action
    Identify all affected devices – see the manufacturer’s Field Safety Notice (FSN) dated 26 June 2017. Contact the distributor to acknowledge receipt of the FSN and to arrange for the lower motor controller board to be replaced as soon as possible.

Device

AlterG Anti-Gravity treadmill, model M320, used for rehabilitation after surgery
  • Model / Serial
  • Product Description
    Treadmills built before 06/06/2016 and with serial numbers lower than M300-1117 are affected.
  • Manufacturer
    Alter G

Manufacturer

Alter G