FDA recall Z-1352-2018

The Magstim Company Limited · Class II · device

Product

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2017-09-28
Report date
2018-04-18
Termination date
2022-06-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Whitland, United Kingdom

Primary source

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