Class 2 Device Recall Repetitive TMS Therapy System

• Date Initiated by Firm: October 25, 2018
• Create Date: February 14, 2019
• Recall Status: Open, Classified
• Recall Number: Z-0836-2019
• Recall Event ID: 81489
• 510(K)Number: K180907
• Product Classification: Transcranial Magnetic Stimulator - Product Code OBP
• Product: HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)
• Code Information: Product #: 5162-00 Serial #'s: 55308/001, 55308/002, 55310/001, 55310/002, 55446/001, 55446/002, 55447/001, 55447-002, 55631-001, 55631-002, 55631-003, 55631-004, 55632/001, 55632/002, 55632/003, 55632/004, 55841/001, 55841-002, 55841-003, 55841-004, 55842/001, 55842/002, 55842/003, 55842/004, 55843-001, PLT00015/001 and PLT00015/002
• Recalling Firm/ Manufacturer: The Magstim Company Limited; Spring Gardens; Whitland United Kingdom
• Manufacturer Reason for Recall: A stray strand of stainless-steel cable may protrude from the heat shrink sleeving on the Balance Cable of the Ez Arm.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On October 26, 2018, the firm sent URGENT FIELD SAFETY NOTICE, Medical Device Recall letters to their consignees to check their devices for this problem.
• Quantity in Commerce: 27 (including 2 demos)
• Distribution: CA, MA, MN, PA, TX, VA, WI, and WA
• 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 Ltd.