Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Repetitive TMS Therapy System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Repetitive TMS Therapy Systemsee related information
Date Initiated by FirmOctober 25, 2018
Create DateFebruary 14, 2019
Recall Status1 Open3, Classified
Recall NumberZ-0836-2019
Recall Event ID 81489
510(K)NumberK180907 
Product Classification Transcranial Magnetic Stimulator - Product Code OBP
ProductHORIZON 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  
FEI Number 3002808356
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 2		Nonconforming Material/Component
ActionOn 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 Commerce27 (including 2 demos)
DistributionCA, MA, MN, PA, TX, VA, WI, and WA
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = OBP
-
-