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Recall Observatory FDA recall evidence

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.

Z-1352-2018

September 28, 2017

Class II

Product summary

Firm
The Magstim Company Limited
Event
Event 79577
Status
Terminated
Classification
Class II
Quantity
43
Official record key
device-enforcement:Z-1352-2018

Official wording

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

Code information: Part # 4800-00T

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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