FDA-Device2018-04-18Class II

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.

The Magstim Company Limited
Hazard

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

Sold states
US Nationwide Distribution in the states of AR, CA, GA, KS, MA, MD, MO, NC, NJ, NW, NY, TX and Hawaii
Affected count
43
Manufactured in
Spring Gardens, Whitland, United Kingdom
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1352-2018

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