Events

Recall of Rapid2 Therapy System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by The Magstim Company Limited.

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
    79577
  • Event Risk Class
    Class 2
  • Event Number
    Z-1352-2018
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162681
  • 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
    Transcranial Magnetic Stimulator - Product Code OBP
  • Reason
    Users manuals not supplied with 4800-00t us rapid therapy system.
  • Action
    On September 28, 2017 the recalling firm sent a Field Safety Notice that included the Operating Manual to all their customers involved in this event. An Acknowledgement card was attached to the letter to be sent back to the recalling firm informing that they received the Operating Manual

Device

Rapid2 Therapy System
  • Model / Serial
    Part # 4800-00T
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of AR, CA, GA, KS, MA, MD, MO, NC, NJ, NW, NY, TX and Hawaii
  • Product Description
    Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air Film Coil and Main Filters || Product Usage For the treatment of major depressive disorders in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
  • Manufacturer
    The Magstim Company Limited

Manufacturer

The Magstim Company Limited
  • Manufacturer Address
    The Magstim Company Limited, Spring Gardens, Whitland United Kingdom
  • Source
    USFDA