PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: April 18, 2018 Initiated: September 28, 2017 #Z-1352-2018

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.

Reason for Recall

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

Details

Units Affected
43
Distribution
US Nationwide Distribution in the states of AR, CA, GA, KS, MA, MD, MO, NC, NJ, NW, NY, TX and Hawaii
Location
Whitland

Frequently Asked Questions

What product 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.. Recalled by The Magstim Company Limited. Units affected: 43.
Why was this product recalled?
Users manuals not supplied with 4800-00T US Rapid Therapy System
Which agency issued this recall?
This recall was issued by the FDA Devices on April 18, 2018. Severity: Moderate. Recall number: Z-1352-2018.