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U.S. Department of Health and Human Services

Class 2 Device Recall Rapid2 Therapy System

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  Class 2 Device Recall Rapid2 Therapy System see related information
Date Initiated by Firm September 28, 2017
Create Date April 11, 2018
Recall Status1 Terminated 3 on June 21, 2022
Recall Number Z-1352-2018
Recall Event ID 79577
510(K)Number K162935  K143531  
Product Classification Transcranial Magnetic Stimulator - Product Code OBP
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.
Code Information Part # 4800-00T
Recalling Firm/
Manufacturer		 The Magstim Company Limited
Spring Gardens
Whitland United Kingdom
For Additional Information Contact Customer Service
888-624-7846
Manufacturer Reason
for Recall		 Users manuals not supplied with 4800-00T US Rapid Therapy System
FDA Determined
Cause 2		 Employee error
Action On September 28, 2017 the recalling firm sent a Field Safety Notice that included the Operating Manual to all their customers involved in this event. An Acknowledgement card was attached to the letter to be sent back to the recalling firm informing that they received the Operating Manual
Quantity in Commerce 43
Distribution US Nationwide Distribution in the states of AR, CA, GA, KS, MA, MD, MO, NC, NJ, NW, NY, TX and Hawaii
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OBP and Original Applicant = MAGSTIM COMPANY LIMITED
510(K)s with Product Code = OBP and Original Applicant = MAGSTIM COMPANY LTD.
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