The Magstim Company Limited recalls Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air…

Recall date

September 28, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1352-2018

FDA classification

Class II

Brand / firm

The Magstim Company Limited

Sold / distributed

US Nationwide Distribution in the states of AR, CA, GA, KS, MA, MD, MO, NC, NJ, NW, NY, TX and Hawaii

Why it was recalled

Users manuals not supplied with 4800-00T US Rapid Therapy System

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.