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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