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U.S. Department of Health and Human Services

Class 2 Device Recall Rapid2

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  Class 2 Device Recall Rapid2 see related information
Date Initiated by Firm March 23, 2020
Create Date May 13, 2020
Recall Status1 Open3, Classified
Recall Number Z-1966-2020
Recall Event ID 85393
510(K)Number K051864  K143531  K162935  K180907  K182853  K183376  
Product Classification Transcranial magnetic stimulator - Product Code OBP
Product Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Code Information Product Code: 3853-00
Recalling Firm/
Manufacturer		 The Magstim Company Limited
Spring Gardens
Whitland United Kingdom
For Additional Information Contact Tom Campbell
612-2255868
Manufacturer Reason
for Recall		 It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The Magstim Company Ltd notified customers on about 3/23/2020 via URGENT FIELD SAFETY NOTICE Medical Device Recall letter. The letter instructed customers to identify all affected products at their facility, raise awareness to all those who need to be aware within their organization, notify customers if the product was further distributed, and complete and return the provided acknowledgement form, so Magstim Company can contact them to arrange replacement of the cable. Once customers have returned the acknowledgement form, Magstim Company will arrange for a new cable to be sent to you or your technical personnel. This will be accompanied by instructions on how to install the new cable. Magstim Technical Service Team can guide you through the installation via telephone or video call. This to limit transmission during the current pandemic COVID-19.
Quantity in Commerce 71 units total
Distribution Worldwide distribution - US Nationwide distribution including in the states of AL, AR, CA, CT, TN, IL, MN, MT, NC, NJ, NY, PA, SC, TX, WA, and the countries of Cyprus, China, Iran, Saudi Arabia, UK, Italy, Malaysia, Spain, Taiwan, Vietnam, Australia, Japan, Turkey, France and Israel.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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.
510(K)s with Product Code = OBP and Original Applicant = THE MAGSTIM COMPANY LTD.
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